Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Temporarily halted
Participants planned
1,200
Countries
11
Sites
101
Metastatic Non-Small Cell Lung Cancer (mNSCLC)
The primary objective of the study is to determine whether volrustomig plus chemotherapy improves PFS and OS when compared with pembrolizumab plus chemotherapy in participants with mNSCLC where PD-L1 < 1%.
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Jun 2024 → ongoing
- Decision date (initial)
- 2024-01-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The primary objective of the study is to determine whether volrustomig plus chemotherapy improves PFS and OS when compared with pembrolizumab plus chemotherapy in participants with mNSCLC where PD-L1 < 1%.
Secondary objectives 1
- The secondary objective of the study is to determine whether volrustomig plus chemotherapy improves PFS and OS in patients with mNSCLC where PD-L1 < 50% when compared with pembrolizumab plus chemotherapy.
Conditions and MedDRA coding
Metastatic Non-Small Cell Lung Cancer (mNSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Period Participants will undergo screening evaluations to determine eligibility within 28 days prior.
|
Not Applicable | None | ||
| 2 | Treatment period All participants across histology subtypes will be randomized in a 1:1 ratio to one of the following intervention groups - experimental arm or control arm.
|
Randomised Controlled | None | Experimental arm: volrustomig in combination with chemotherapy Control Arm: pembrolizumab in combination with chemotherapy |
|
| 3 | Follow up period All participants will undergo a follow-up visit 21 days after their last dose of study intervention and a safety follow-up visit 90 days after their last dose of study intervention.
|
Randomised Controlled | None |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-003423-PIP01-23
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histologically or cytologically documented squamous or non-squamous NSCLC. Stage IV NSCLC (according to Version 8 of the IASLC Staging
- Provision of tumor sample for prospective PD-L1 testing .
- PD-L1 <50%.
- Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK and ROS1 rearrangements.
- Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes (eg, NTRK, BRAF, RET, MET, etc.) for which there are locally approved targeted first-line therapies.
Exclusion criteria 7
- Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes (eg, NUT carcinoma, thoracic SMARCA4-deficient undifferentiated tumor, adenoid cystic carcinoma, epithelial-myoepithelial carcinoma) are excluded.
- No prior exposure to immunotherapy.
- No medical contraindication to platinum-based treatment.
- Spinal cord compression.
- Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
- History of another primary malignancy except for: (a) Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. (c) Adequately treated carcinoma in situ without evidence of disease.
- As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Progression-Free Survival (PFS) in PD-L1 <1% (using BICR assessments according to RECIST 1.1); PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants where PD-L1 <1%.
- Overall Survival (OS) in PD-L1 <1%; OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants where PD-L1 < 1%.
Secondary endpoints 2
- Overall survival in all randomized patients
- Progression Free Survival in all randomized participants.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10191166 · Product
- Active substance
- Volrustomig
- Substance synonyms
- MEDI5752, Human IgG1 monoclonal antibody with an engineered Fc domain targeting PD-1 and CTLA-4
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 5
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
PRD8505443 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1071/004
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mycofit, 250 mg, kapsułki twarde
PRD391929 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 3 g gram(s)
- Max total dose
- 00 g gram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- 16297
- MA holder
- ACCORD HEALTHCARE POLSKA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Remsima 100 mg powder for concentrate for solution for infusion
PRD2620214 · Product
- Active substance
- Infliximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/853/002
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD10240124 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 6 Other
- Max total dose
- 00 Other
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 3002152.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paclitaxel Bendalis 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD8983541 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 88691.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
11 EU/EEA countries · 101 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Temporarily halted | 8 | 2 |
| Belgium | Temporarily halted | 14 | 5 |
| Czechia | Temporarily halted | 15 | 5 |
| France | Temporarily halted | 90 | 18 |
| Germany | Temporarily halted | 81 | 20 |
| Hungary | Temporarily halted | 45 | 14 |
| Italy | Temporarily halted | 46 | 9 |
| Netherlands | Temporarily halted | 14 | 4 |
| Poland | Temporarily halted | 48 | 12 |
| Slovakia | Temporarily halted | 11 | 5 |
| Spain | Temporarily halted | 65 | 7 |
| Rest of world
United States, South Africa, Taiwan, Australia, Brazil, China, Canada, United Kingdom, Thailand, Japan, Argentina, India
|
— | 763 | — |
Investigational sites
Kepler Universitaetsklinikum GmbH
Universitätsklinik für Innere Medizin 4 - Pneumologie, Krankenhausstrasse 9, 4020, Linz
Klinikum Wels-Grieskirchen GmbH
Division for lung diseases, Grieskirchner Strasse 42, 4600, Wels
Onze-Lieve-Vrouwziekenhuis
Pneumologie, Moorselbaan 164, 9300, Aalst
AZ Vesalius
Pneumologie, Hazelereik 51, 3700, Tongeren
Az Sint-Lucas & Volkskliniek
Pneumologie, Groenebriel 1, 9000, Gent
Universitair Ziekenhuis Gent
Pneumologie, Corneel Heymanslaan 10, 9000, Gent
Het Ziekenhuisnetwerk Antwerpen
Pneumologie, Lindendreef 1, 2020, Antwerp
Fakultni Thomayerova nemocnice
Pneumologická klinika, Videnska 800, Krc, Prague 4
University Hospital Olomouc
Klinika plicních nemocí a tuberkulózy, Zdravotniku 248/7, 779 00, Olomouc
Nemocnice AGEL Ostrava-Vitkovice a.s.
Plicní oddělení, budova A1-1.patro, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Fakultni Thomayerova nemocnice
Pneumologicka klinika, Videnska 800, Krc, Prague
Vseobecna Fakultni Nemocnice V Praze
Onkologická klinika VFN a 1. LF UK, U Nemocnice 499/2, Nove Mesto, Prague 2
Centre Hospitalier Intercommunal De Cornouaille
Service de Pneumologie, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Hospital Foch
Oncologie et soins de supports, 40 Rue Worth, 92150, Suresnes
Centre Hospitalier De Saint Malo
Service des Maladies Infectieuses et Respiratoires, 1 Rue De La Marne, 35403, Saint-Malo Cedex
Centre Hospitalier Universitaire De Caen Normandie
Service de Pneumologie et d’Oncologie Thoracique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Institut Paoli-Calmettes
Service d'Oncologie Médicale, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Les Hopitaux Universitaires De Strasbourg
Oncologie Thoracique, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire Reims
Service des Maladies Respiratoires, Rue Du General Koenig, 51092, Reims Cedex
Centre Hospitalier De La Cote Basque
Service de Pneumologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier D Avignon
Onco-Hematologie, 305 Rue Raoul Follereau, 84000, Avignon
Centre Hospitalier Et Universitaire De Limoges
Pneumology UOT, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Hospitalier Universitaire De Lille
Service de pneumologie et oncologie thoracique, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hopitaux Prives De Metz
Service de Pneumologie, Parvis Schuman Rue Champs Montoy, Rue Pre Montois, Vantoux
Centre Hospitalier Universitaire De Bordeaux
Service des Maladies Respiratoires, Avenue De Magellan, 33600, Pessac
Institut Curie
INSTITUT DU THORAX, 35 Rue Dailly, 92210, Saint-Cloud
Institut Regional Du Cancer De Montpellier
Oncologie Medicale, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut De Cancerologie De L Ouest
Oncologie, Bd Du Professeur Jacques Monod, 44800, St Herblain
HIA Sainte Anne
Department of Oncology-Pneumology, 2 Boulevard Sainte Anne, Bp 600, Toulon Cedex 9
Institut Bergonie
Oncologie Medicale, 229 Cours De L Argonne, 33000, Bordeaux
MVZ-Onkologie Velbert GbR
-, Friedrichstrasse 311, Mitte, Velbert
HELIOS Klinikum Emil von Behring GmbH
Lungenklinik Heckeshorn, Walterhoeferstrasse 11, Zehlendorf, Berlin
Städtisches Klinikum Braunschweig gGmbH
Medizinische Klinik III, Hämatologie und Onkologie, Celler Straße 38, 38114, Braunschweg
Medical Center - University Of Freiburg
Department of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
KEM I Evang. Kliniken Essen-Mitte gGmbH
MVZ Haematologie und Onkologie, Henricistrasse 92, Huttrop, Essen
Katholisches Marienkrankenhaus gGmbH
Onkologische Tagesklinik, Alfredstrasse 9, Hohenfelde, Hamburg
Universitaetsklinikum Tuebingen AöR
Medizinische Onkologie und Pneumologie, Innere Medizin VIII, Otfried-Mueller-Strasse 14, Nordstadt, Tuebingen
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik II - Innere Medizin, Venusberg-Campus 1, Venusberg, Bonn
Franziskus Hospital Harderberg
Klinik für Thoraxonkologie, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
Lungenfachklinik Immenhausen
Zentrum für Pneumologie, Robert Koch Strasse 3, 34376, Immenhausen
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Praxis fuer Haematologie und Onkologie, Neversstrasse 5, Sued, Koblenz
Onkodok GmbH
-, Brunnenstrasse 14, Innenstadt, Guetersloh
Klinikum Nuernberg
Klinik für Innere Medizin 3, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Asklepios Fachkliniken Muenchen Gauting
Thorakale Onkologie, Robert-Koch-Allee 2, 82131, Gauting
RKH Regionale Kliniken Holding und Services GmbH
Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie, Posilipostrasse 4, Mitte, Ludwigsburg
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Klinik für Innere Medizin II, Roentgenstrasse 1, Doelau, Halle (saale)
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Johanniter GmbH
Innere Medizin, Johanniterstrasse 3-5, Zentrum, Bonn
Thoraxklinik Heidelberg gGmbH
Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg
MVZ fuer Haematologie und Onkologie Koeln Am Sachsenring GmbH
-, Sachsenring 69, Neustadt-Sued, Cologne
Matrai Gyogyintezet
n/a, Matrahaza Hrsz 7151, 3200, Gyongyos
Tolna Megyei Balassa Janos Korhaz
Onkológiai Osztály, Beri Balogh Adam Utca 5-7, 7100, Szekszard
Orszagos Onkologiai Intezet
Gyógyszerterápiás Központ Mellkasi és Hasüregi Daganatok és Klinikai Farm. Osztály "Kemoterápia B", Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Koranyi National Institute For Pulmonology
I. Tüdőgyógyászati Osztály, Koranyi Frigyes Ut 1, 1121, Budapest XII
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Pulmonológiai Osztály, Vasvari Pal Utca 2-4, 9024, Gyor
Toeroekbalinti Tuedogyogyintezet
n/a, Munkacsy Mihaly Utca 70, 2045, Torokbalint
University Of Debrecen
Tüdőgyógyászati Klinika, Nagyerdei Korut 98, 4032, Debrecen
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Pulmonológia Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Clinexpert Kft.
n/a, Dozsa Gyorgy Utca 15, 3200, Gyongyos
Orszagos Koranyi Pulmonologiai Intezet
I. Tüdőgyógyászati Osztály, Koranyi Frigyes Ut 1, 1121, Budapest XII
Reformatus Pulmonologiai Centrum
n/a, Munkacsy Mihaly Utca 70, 2045, Torokbalint
University Of Pecs
Klinikai Központ, Onkoterápiás Intézet, Edesanyak Utja 17, 7624, Pecs
Bacs-Kiskun Varmegyei Oktatokorhaz
Onkoradiológiai Központ, Nyiri Ut 38, 6000, Kecskemet
Semmelweis University
Pulmonológiai Klinika, Tomo Utca 25-29, 1083, Budapest VIII
Azienda Ospedaliera Universitaria Renato Dulbecco
Oncoematology, Viale Tommaso Campanella 115, 88100, Catanzaro
Fondazione Policlinico Universitario Campus Bio-Medico
Medical Oncology, Via Alvaro Del Portillo N 200, 00128, Rome
Istituto Oncologico Veneto
CLINICAL AND EXPERIMENTAL ONCOLOGY, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero Universitaria Parma
Medical Oncology, Viale Antonio Gramsci 14, 43126, Parma
Fondazione IRCCS Policlinico San Matteo
UOC Oncology I, Viale Camillo Golgi 19, 27100, Pavia
Cliniche Gavazzeni S.p.A.
Medical Oncology, Via Mauro Gavazzeni 21, 24125, Bergamo
ASST Grande Ospedale Metropolitano Niguarda
Ematology, Oncology and Molecular Medicine, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Unita Sanitaria Locale Della Romagna
Oncologia, Via Alcide De Gasperi 8, 48121, Ravenna
Istituto Tumori Bari Giovanni Paolo II
Medical Oncology for thoracic pathology, Viale Orazio Flacco 65, 70124, Bari
Amsterdam UMC
Longziekten, De Boelelaan 1117, 1081 HV, Amsterdam
Sint Antonius Ziekenhuis Stichting
Longziekten, Koekoekslaan 1, 3435 CM, Nieuwegein
Elisabeth-Tweesteden Ziekenhuis
Longgeneeskunde, Dr. Deelenlaan 5, 5042 AD, Tilburg
Stichting Martini Ziekenhuis
Longziekten, Van Swietenplein 1, 9728 NT, Groningen
Medicover Integrated Clinical Services Sp. z o.o.
n/a, Ul. Stefana Batorego 18/22, 87-100, Torun
Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow
Oddzial Kliniczny Pulmonologii Ogolnej i Onkologicznej, Ul. Stefana Zeromskiego 113, 90-549, Lodz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworow Pluca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
TBC, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oddzial Onkologiczny z Pododdzialem Dziennej Chemioterapii, Ul. Monte Cassino 18, 37-700, Peremyshl
Izerskie Centrum Pulmonologii I Chemioterapii Izer-Med Sp. z o.o.
Oddzial Chemioterapii Nowotworow, Ul. Sanatoryjna 1, 58-580, Szklarska Poreba
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Oddzial Onkologii Klinicznej, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
National Institute Of Tuberculosis And Lung Diseases
3 Klinika Chorob Pluc i Onkologii, Ul. Plocka 26, 01-138, Warsaw
Kliniki Neuroradiochirurgii Sp. z o.o.
Kliniczny Oddzial Chemioterapii, Ul. Uniwersytecka 6a, 26-601, Radom
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddzial Onkologii Klinicznej z Pododzialem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddzial Onkologii z Pododdzialem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Klinika Pulmonologii i Chemioterapii, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
F D Roosevelt University General Hospital Of Banska Bystrica
Department of Pneumology and Phthisiology, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Fakultna Nemocnica Trnava
Department of Oncology, Andreja Zarnova 11, 917 02, Trnava
Vychodoslovensky Onkologicky Ustav a.s.
Department of Clinical Oncology, Rastislavova 43, Juh, Kosice
Narodny Onkologicky Ustav
Department of Clinical Oncology E, Klenova 1, Nove Mesto, Bratislava
University Hospital Bratislava
Department of Pneumology and Phthisiology, Ruzinovska 6, Ruzinov, Bratislava
Hospital Son Llatzer
Oncology, Carretera De Manacor Km 4, 07198, Palma
Hospital General Universitario Dr. Balmis
Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Basurto
Oncology, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-07-31 | 2024-08-29 | 2025-11-14 | ||
| Belgium | 2024-07-11 | 2024-11-25 | 2025-11-14 | ||
| Czechia | 2024-09-08 | 2024-09-10 | 2025-11-14 | ||
| France | 2024-06-13 | 2024-06-25 | 2025-11-14 | ||
| Germany | 2024-06-26 | 2024-07-16 | 2025-11-14 | ||
| Hungary | 2024-07-09 | 2024-07-19 | 2025-11-14 | ||
| Italy | 2024-06-25 | 2024-07-15 | 2025-11-14 | ||
| Netherlands | 2024-07-01 | 2024-10-08 | 2025-11-14 | ||
| Poland | 2024-06-24 | 2024-06-28 | 2025-11-14 | ||
| Slovakia | 2024-08-13 | 2024-11-18 | 2025-11-14 | ||
| Spain | 2024-06-18 | 2024-06-19 | 2025-11-14 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 11 · Art. 38 CTR
Temporary halt TH-108481
- Halt date
- 2025-11-14
- Member states concerned
- Italy
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108480
- Halt date
- 2025-11-14
- Member states concerned
- Hungary
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108483
- Halt date
- 2025-11-14
- Member states concerned
- Netherlands
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108482
- Halt date
- 2025-11-14
- Member states concerned
- Spain
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108478
- Halt date
- 2025-11-14
- Member states concerned
- France
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108477
- Halt date
- 2025-11-14
- Member states concerned
- Czechia
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108479
- Halt date
- 2025-11-14
- Member states concerned
- Germany
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108485
- Halt date
- 2025-11-14
- Member states concerned
- Slovakia
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108473
- Halt date
- 2025-11-14
- Member states concerned
- Austria
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108484
- Halt date
- 2025-11-14
- Member states concerned
- Poland
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108475
- Halt date
- 2025-11-14
- Member states concerned
- Belgium
- Publication date
- 2025-11-28
- Reason
- Sponsor decision
- Explanation
- Following a routine review of study data, the Independent Data Monitoring Committee (IDMC) recommended an immediate pause in recruitment on the eVOLVE-Lung02 study. The IDMC has determined that the study should otherwise continue as planned and currently randomized patients should continue per protocol.
As a result of the IDMC recommendation, AstraZeneca implemented a pause in recruitment effective on Friday, 14 November 2025. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-24848
- Event date
- 2024-05-13
- Submission date
- 2024-05-13
- In response to
- OTHER
- Member states affected
- Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Spain, Netherlands, Poland, Slovakia
- Event description
- An event of hepatic failure with fatal outcome was reported from the study eVOLVE-LUNG02 for a patient with metastatic non-small cell lung cancer receiving volrustomig and chemotherapy. The patient had normal baseline liver function and received 3 cycles of study treatment with ALT and AST within the normal range during this time. They then developed grade 1 elevation of ALT and AST on cycle 4 day 1 and reported nausea and weight loss during cycle 4. Protocol-required blood tests conducted in preparation for cycle 5 showed elevated ALT, AST and total bilirubin (ALT /AST > x 50 upper limit of normal (ULN), Total Bilirubin > x 6 ULN). Despite starting immunosuppressive therapy the patient died 5 days after admission due to multi-organ failure as a result of hepatic insufficiency.
Hepatic events are recognised as an important identified risk for volrustomig per the current Investigator’s Brochure v.6.1. Following the event, AstraZeneca has conducted a review of hepatic safety data from the volrustomig clinical programme. As a result of this review, AstraZeneca is implementing additional preventative safety measures including changes to the liver monitoring schedule and toxicity management guidelines for all studies involving volrustomig. - Measures taken
- Dear Doctor Letter being sent to all investigators involved in AZ sponsored studies in the volrustomig program to inform them about the important safety event with volrustomig. The memo includes details of the urgent measures for sites to implement. The measures include an increased frequency of liver function test monitoring, updated toxicity management guidelines for hepatic events, a directive for communication with patients on the important safety event and increased monitoring and mandated actions to ensure appropriate documentation of the memo by the site.
Dear Doctor Letter being sent to all collaborators involved in the AZ sponsored ESR program who have submitted protocols for regulatory review to inform them of the Important safety event and recommendations for protocol updates.
The clinical study protocol, toxicity management guidelines, and informed consent form will be amended accordingly and submitted to health authorities and/or local institutional review boards/ethics committees (IRBs/ECs).
Corrective measures 2 · Art. 77 CTR
Corrective measure CM-HU-0002
- Member state
- Hungary
- Publication date
- 2025-02-04
- Type
- 3
- Reason
- 7
- Immediate action required
- No
- Justification
- 2023-503298-39-00 CTIS azonosítószámú, D798AC00001 protokoll számú vizsgálatban a Clinexpert Kft. Fázis I vizsgálóhelyet (Gyöngyös, vizsgálatvezető Dr. Albert István) az ETT Klinikai Farmakológiai Etikai Bizottság nem kifogásolta. Későbbiekben kiderült, hogy bár a vizsgálatvezető megfelelő szakmai kvalifikációval rendelkezik, maga a vizsgálóhely nem alkalmas sem tüdőgyógyászati, sem onkológiai betegek ellátására sem fekvő-, sem járóbetegek esetében. A Bizottság kéri a vizsgálóhely bezárását és a jelenleg beválasztott betegek áthelyezését a Mátrai Gyógyintézet, Mátraháza vizsgálóhelyre, amely egészségügyi szolgáltató teljes mértékben jogosult és alkalmas ezen betegek ellátására, továbbá a vizsgálatvezető, önéletrajza szerint ott osztályvezető főorvosi pozíciót tölt be. A kapcsolódó dokumentumokat SM formájában kérjük benyújtani 1 hónapon belül.
Corrective measure CM-HU-0003
- Member state
- Hungary
- Publication date
- 2025-02-21
- Type
- 3
- Reason
- 7
- Immediate action required
- No
- Justification
- Referring to CM-HU-0002 and consultation on 03 Feb 2025 we ask the sponsor to submit a plan on corrective actions, and inform patients about the issue. As we couldn't raise 2nd RFI during CM-HU-0002 procedure due to the limation on CTIS, we initiated this new CM. Please consider it as the follow up of CM-HU-0002.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 165 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503298-39-00_redacted | 5.0 |
| Protocol (for publication) | D1_tmg_medi5752 | 4.0 |
| Protocol (for publication) | D1_tmg_Volrustomig_redacted | 5.0 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements NL | NA |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitments arrangements | 1.1 |
| Recruitment arrangements (for publication) | K2 Recruitment Material Pamphlet | 2.0 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Patient Poster_BE Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Patient Poster_BE English | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Patient Poster_BE French | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Patient Poster_NL Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Patient Recruitment Pamphlet_BE Dutch_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Patient Recruitment Pamphlet_BE English_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Patient Recruitment Pamphlet_BE French_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Patient Recruitment Pamphlet_NL Dutch_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material pamphlet | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material pamphlet_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Poster Lenticular Sticker | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pamphlet_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Recruitment Pamphlet_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1.0 |
| Subject information and informed consent form (for publication) | CZ RA_Confirmation about use of checkboxes in Informed consent Form_Redacted | NA |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Addendum PL | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult PL_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_Dutch_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_English_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_French_redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Biomarker for Adult_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Biomarker Testing PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Biomarker_BE_French_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Genetic_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF optional genetic PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_Dutch_clean | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_English_clean | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_French_clean | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partners PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partners_clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_Dutch_clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_English_clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_French_clean | 1.0 |
| Subject information and informed consent form (for publication) | L1_List of the submitted HU ICFs | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Adult_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Clinexpert | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Future Research SK_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Optional Biopsies SK_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Personal Data SK_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Progression SK | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_for_treatment_beyond_progression | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult for already enrolled patients_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Subject SK_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_German_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker for Adult_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker_BE_Dutch_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biomarker_BE_English_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF biomarker_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Adult_IT_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Genetic Research_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partners | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_German_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future research_German_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic biomarkers_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_German_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Subject SK_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic_German_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_HU_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional future_HU_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF optional genetic_HU_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 2.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_German | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_German | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner_HU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partners SK | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_German | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Genetic Research Addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to ICF - Optional Tumor Biopsy_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to ICF Handling of Personal Data for already enrolled patients_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to ICF Handling of Personal Data_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult subject ICF_Redacted | 5.0 ES 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biological Sample Research Addendum to ICF for already enrolled patients_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Biological Sample Research Addendum to ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic ICF_Redacted | 1.0 ES 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF for Contact with Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomaker ICF_Redacted | 2.0 ES 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partners ICF | 1.0 ES 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TBP ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment after progression | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Tbp Addendum ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_Site specific data of the clinical trial sites_Austria_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Thank You Cards SK | 1.0 |
| Subject information and informed consent form (for publication) | L2_App Subject Facing Screen Report V1_SK | 1.0 |
| Subject information and informed consent form (for publication) | L2_Guidance on Trial Max application_SK | 1.0 |
| Subject information and informed consent form (for publication) | L2_Justification of use of e-code in participation card_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material alert card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Study Participation Card_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Patient reimbursement claim | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Patient reimbursement information | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Patient reimbursement personal data form | 5.0 |
| Subject information and informed consent form (for publication) | L2_Part II_Other subject information material_A-1032-0270-5151QRG_csCZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Part II_Other subject information material_App Subject Facing Screen Report_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L2_Part II_Other subject information material_Patient card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Part II_Other subject information material_Patient questionnaire_Redacted | NA |
| Subject information and informed consent form (for publication) | L2_Patient card HU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Web Subject Facing Screen Report V1_SK | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_RSI Pembrolizumabpembrolizumab_Redacted | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC - Pembrolizumab | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Language ENG 2023-503298-39-00_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay language_FR_2023-503298-39-00_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis CZ_2023-503298-39-00_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG_2023-503298-39-00_redacted | 9.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis LL HU_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Scientific HU_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_2023-503298-39-00_redacted | 9.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE Dutch 2023 503298 39_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE French 2023 503298 39_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE German 2023 503298 39_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-503298-39-00_redacted | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_lay language_BE Dutch_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_lay language_BE French_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_lay language_BE German_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay language_ES_2023-503298-39_Redacted | 4.0 ES |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay language_IT_2023-503298-39-00_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay Language_NL_2023-503298-39_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_lay language_PL_2023-503298-39-00_Redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SK_2023-503298-39_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D4 Patient facing documents BE FR_Patient Reported Outcomes questionnaires_redacted | NA |
| Synopsis of the protocol (for publication) | D4 Patient facing documents BE NL_Patient Reported Outcomes questionnaires_redacted | NA |
| Synopsis of the protocol (for publication) | D4 Patient facing documents_Patient Reported Outcomes questionnaires HU_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_9x questionnaires_ES_Redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_9x questionnaries_SK_Slovak_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_9x_questionnaries_PL_Poland_Redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Pamphlet_AT German_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Pamphlet_BE Dutch_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Pamphlet_BE English_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Pamphlet_BE French_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Pamphlet_NL Dutch_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Patient Reported Outcomes questionnaires NL_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Questionnaires_AT_German_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Questionnaires_DE_German_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Questionnaires_IT_Italian_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient-facing document_justification statement | NA |
| Synopsis of the protocol (for publication) | D4_Patient-facing document_PGI-C | 1.0 |
| Synopsis of the protocol (for publication) | D4_Patient-facing document_PGI-S | 1.0 |
| Synopsis of the protocol (for publication) | D4_Patient-facing document_PGI-TT | 1.0 |
| Synopsis of the protocol (for publication) | D4_Patient-facing documents_eVolve-lung-02_pamphlet_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D4_Patients facing documents_9-FR_redacted | NA |
| Synopsis of the protocol (for publication) | D4_study participation cards_redacted | 1.0 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Belgium | Acceptable with conditions 2024-01-23
|
2024-01-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-23 | Belgium | Acceptable with conditions 2024-05-30
|
2024-05-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-18 | Belgium | Acceptable with conditions 2024-05-30
|
2024-06-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-26 | Belgium | Acceptable with conditions 2024-09-27
|
2024-09-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-10 | Acceptable with conditions 2024-09-27
|
||
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-12-10 | Acceptable with conditions 2024-09-27
|
2024-12-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-17 | Belgium | Acceptable 2025-02-25
|
2025-02-27 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-04-14 | Acceptable 2025-02-25
|
2025-04-14 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-16 | Belgium | Acceptable | 2025-05-09 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-05-13 | Acceptable | 2025-05-13 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-05-13 | Acceptable | 2025-05-13 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-19 | Belgium | Acceptable 2025-07-17
|
2025-07-17 |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-04 | Belgium | Acceptable 2025-11-04
|
2025-11-04 |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-01-29 | Belgium | Acceptable 2026-04-02
|
2026-04-02 |