Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
825
Countries
9
Sites
57
Unresectable Pleural Mesothelioma
The primary objective is to demonstrate the superiority of volrustomig in combination with carboplatin plus pemetrexed relative to investigator’s choice of nivolumab in combination with ipilimumab or platinum plus pemetrexed by assessment of OS in participants with pleural mesothelioma.
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
- 26 Apr 2024 → ongoing
- Decision date (initial)
- 2023-12-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB (Södertälje 151 85, Sweden)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The primary objective is to demonstrate the superiority of volrustomig in combination with carboplatin plus pemetrexed relative to investigator’s choice of nivolumab in combination with ipilimumab or platinum plus pemetrexed by assessment of OS in participants with pleural mesothelioma.
Secondary objectives 5
- Demonstrate the effectiveness of volrustomig+carboplatin+pemetrexed relative to investigator’s choice of nivolumab+ipilimumab or platinum+pemetrexed by assessment of OS, PFS, ORR, DoR, and PFS2
- Assess patient-reported physical functioning, disease-related symptoms, patient-reported role functioning and HRQoL, in participants receiving volrustomig+carboplatin+pemetrexed compared to investigator’s choice of nivolumab+ipilimumab or platinum+pemetrexed
- Investigate the immunogenicity of volrustomig
- Assess the pharmacokinetics of volrustomig
- Assess the safety and tolerability of volrustomig+carboplatin+pemetrexed compared to investigator’s choice of nivolumab+ipilimumab or platinum+pemetrexed
Conditions and MedDRA coding
Unresectable Pleural Mesothelioma
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 to
first treatment
|
Randomised Controlled | 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 carboplatin+pemetrexed Epithelioid Control arm: investigator choice: 1. Nivolumab + Ipilimumab 2. pemetrexed +cisplatin or pemetrexed + carboplatin Non-epithelioid Control arm: Nivolumab + Ipilimumab |
|
| 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 6
- Participant must be ≥ 18 years at the time of screening
- Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid or non-epithelioid)
- Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy)
- WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS>1) over the previous 2 weeks prior to day of first dosing
- Has measurable disease per modified RECIST1.1
- Has adequate bone marrow reserve and organ function at baseline
Exclusion criteria 7
- As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results
- Active or prior documented autoimmune or inflammatory disorders
- History of another primary malignancy with exceptions.
- Uncontrolled intercurrent illness
- Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled
- Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment
- Untreated or progressive CNS metastatic disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- overall survival
Secondary endpoints 5
- Overall Survival and Progression Free Survival, OS and PFS at specific landmarks, Overall Response Rate, Duration of Response, and PFS2 (time from randomization to the second progression event).
- TTD in physical functioning, change from baseline in disease-related symptoms, and in functioning
- Incidence of ADAs against volrustomig.
- Concentrations of volrustomig and PK parameters as data allow
- Safety and tolerability based on AEs, rates of AE-related dose discontinuations/modifications, vital signs, clinical laboratory assessments, physical examinations, and ECGs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
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
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 5
SUB29397 · Substance
- Active substance
- Ipilimumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 210 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB122750 · Substance
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SUB02681MIG · Substance
- 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
- - — -
- Marketing authorisation
- -
- 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
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
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Rigshospitalet ORG-100002431
|
Copenhagen Oe, Denmark | On site monitoring |
| Region Midtjylland ORG-100009397
|
Aarhus N, Denmark | On site monitoring |
Locations
9 EU/EEA countries · 57 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 21 | 5 |
| Denmark | Ongoing, recruitment ended | 10 | 2 |
| France | Ongoing, recruitment ended | 96 | 12 |
| Germany | Ongoing, recruitment ended | 47 | 13 |
| Italy | Ongoing, recruitment ended | 98 | 10 |
| Netherlands | Ongoing, recruitment ended | 25 | 3 |
| Norway | Ongoing, recruitment ended | 15 | 2 |
| Poland | Ongoing, recruitment ended | 34 | 6 |
| Spain | Ongoing, recruitment ended | 37 | 4 |
| Rest of world
South Africa, Canada, United States, United Kingdom, Australia, China, Brazil, Turkey, Japan, Korea, Republic of, Switzerland, Taiwan
|
— | 442 | — |
Investigational sites
Jessa Ziekenhuis
Pneumology, Stadsomvaart 11, 3500, Hasselt
Vitaz
Pneumologie, Moerlandstraat 1, 9100, Sint-Niklaas
Universitair Ziekenhuis Gent
Pneumology, Corneel Heymanslaan 10, 9000, Gent
Het Ziekenhuisnetwerk Antwerpen
Respiratory, Lindendreef 1, 2020, Antwerp
Institut Jules Bordet
Thoracic Oncology, Mijlenmeersstraat 90, 1070, Brussels
Region Midtjylland
Clinical Research Unit, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
Dept. of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Intercommunal Creteil
Pneumologie, 40 Avenue De Verdun, 94000, Creteil
Centre Hospitalier Regional Et Universitaire De Brest
Oncologie, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Universitaire De Lille
Pneumologie et Oncologie Thoracique, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Les Hopitaux Universitaires De Strasbourg
Pneumologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Le Mans
Pneumologie et Oncologie Thoracique, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire De Nantes
Oncologie médicale, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Leon Berard
Oncologie médicale, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Toulouse
Pneumologie, 24 Chemin De Pouvourville, 31400, Toulouse
CHU De Rouen
Oncologie Thoracique, 1 Rue De Germont, Bp 96031, Rouen Cedex
Assistance Publique Hopitaux De Paris
Oncologie Thoracique, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Institut Regional Du Cancer De Montpellier
Pneumologie et Oncologie Thoracique, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Assistance Publique Hopitaux De Marseille
Oncologie, 265 Chemin Des Bourrely, 13015, Marseille
Universitaetsklinikum Schleswig-Holstein AöR
Universitaetsklinikum Schleswig-Holstein AöR, Arnold-Heller-Strasse 3, Brunswik, Kiel
Thoraxklinik Heidelberg gGmbH
Thoraxklinik/Thoraxonkologie Mesotheliomeinheit des NCT, Roentgenstrasse 1, Rohrbach, Heidelberg
Franziskus Hospital Harderberg
Klinik für Thoraxonkologie, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
Mesotheliomeinheit, Dueesbergweg 128, Dueesberg, Muenster
Augusta-Kranken-Anstalt gGmbH
Augusta-Kranken-Anstalt gGmbH, Bergstrasse 26, Grumme, Bochum
Asklepios Fachkliniken Muenchen Gauting
Thorakale Onkologie/ onkologische Studien, Robert-Koch-Allee 2, 82131, Gauting
Asklepios Kliniken Hamburg GmbH
Asklepios Kliniken Hamburg GmbH, Eissendorfer Pferdeweg 52, Heimfeld, Hamburg
Universitaetsklinikum Essen AöR
Innere Klinik (Tumorforschung)/Westdeutsches Tumorzentrum, Hufelandstrasse 55, Holsterhausen, Essen
LungenClinic Grosshansdorf GmbH
NA, Woehrendamm 80, 22927, Grosshansdorf
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Klinik für Onkologie und Hämatologie, Pruefeninger Strasse 86, Westenviertel, Regensburg
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Klinik für Pneumologie, Lindenberger Weg 27, Buch, Berlin
Kliniken der Stadt Koeln gGmbH
Mesotheliomeinheit Köln – Merheim, Ostmerheimer Strasse 200, Merheim, Cologne
HELIOS Klinikum Emil von Behring GmbH
HELIOS Klinikum Emil von Behring GmbH, Walterhoeferstrasse 11, Zehlendorf, Berlin
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo, Via Venezia 16, 15121, Alexandria
Istituto Oncologico Veneto
ISTITUTO ONCOLOGICO VENETO IRCCS, Via Gattamelata 64, 35128, Padova
Humanitas Research Hospital
Humanitas Cancer Center, Via Alessandro Manzoni 56, 20089, Rozzano
European Institute Of Oncology S.r.l.
Divisione di Oncologia Toracica, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Tumori Bari Giovanni Paolo II
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico, Viale Orazio Flacco 65, 70124, Bari
Humanitas Gavazzeni
Presidio Ospedaliero Humanitas Gavazzeni, Via Mauro Gavazzeni 21, 24125, Bergamo
Azienda Ospedaliero Universitaria Parma
Azienda Ospedaliero Universitaria di Parma, Viale Antonio Gramsci 14, 43126, Parma
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department of Oncology, Regione Gonzole 10, 10043, Orbassano
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Oncology, Viale Luigi Borri N 57, 21100, Varese
Fondazione IRCCS San Gerardo Dei Tintori
ASST di Monza (Presidio San Gerardo), Via Giovanni Battista Pergolesi 33, 20900, Monza
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Thoracic Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
TBC, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Catharina Ziekenhuis Stichting
TBC, Michelangelolaan 2, 5623 EJ, Eindhoven
Akershus University Hospital
Lungeavdeling Ahus, Sykehusveien 25, 1474, Loerenskog
Oslo University Hospital HF
Avdeling for lungekreft behandling Ullevål, P. O. Box 4950, 0424, Oslo
Centrum Pulmonologii I Torakochirurgii W Bystrej
Oddzial Pulmonologiczno-Onkologiczny z Chemioterapia, Ul. Juliana Falata 2, Bystra, Wilkowice
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddzial Onkologii z Pododdzialem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworow Pluca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Klinika Pulmonologii i Chemioterapii, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddzial Onkologii z Pododdzialem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Hospital Universitario 12 De Octubre
Servicio de Oncología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitari Vall D Hebron
Servicio de Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario De Cruces
Servicio de Oncología, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Central De Asturias
Servicio de Oncología, Avenida De Roma S/n, 33011, Oviedo
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 |
|---|---|---|---|---|---|
| Belgium | 2024-05-21 | 2024-08-27 | 2026-01-14 | ||
| Denmark | 2024-06-05 | 2024-08-28 | 2026-01-14 | ||
| France | 2024-04-26 | 2024-04-26 | 2026-01-14 | ||
| Germany | 2024-05-15 | 2024-05-27 | 2026-05-12 | ||
| Italy | 2024-05-30 | 2024-06-04 | 2025-12-19 | ||
| Netherlands | 2024-05-28 | 2024-09-12 | 2026-01-14 | ||
| Norway | 2024-06-04 | 2024-06-19 | 2026-01-14 | ||
| Poland | 2024-05-15 | 2024-05-15 | 2025-11-04 | ||
| Spain | 2024-05-30 | 2024-06-04 | 2026-01-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 105 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503231-17-00 Redacted | 5.0 |
| Protocol (for publication) | D1_TMG_Volrustomig_Redacted | 5.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangement_PL | NA |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 5.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements NL | 3.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_DK | 6.0 |
| Recruitment arrangements (for publication) | K1_Leaflet_Dutch_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Leaflet_Fr_EU CTR_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Leaflet_French_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Leaflet_German_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Leaflet_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Patient Leaflet_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CL | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_EU CTR | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Leaflet_es redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redacted | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material Leaflet_DK_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment material Leaflet_NO_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material pamphlet_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Leaflet_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults Optional Samples_DK_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults PL_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_Dutch_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_English_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_BE_French_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_DK_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_Dutch_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_NO_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Appendix_NO_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Future research_DK_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Master_Redacted | 5.0es2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Genomic PL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnancy_Dutch | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_Dutch_clean | 6.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_English_clean | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_BE_French_clean | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_DK | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_EU CTR | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_NO | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partners PL | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression PL | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_BE_Dutch_clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_DK | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_Dutch | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_English_clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_French_clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment beyond progression_NO | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and Pregnant Partner ICF_Redacted | 2.0 ES |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner addendum_EU CTR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Main with optional genetic research_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults Participants_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for adult_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Genetic Research_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partners_CL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for TBP Addendum_CL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main with optional genetic research_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Genetics_Redacted | 3.0es2.0 |
| 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 Translation Certificate_ENG | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression Addendum ICF_German | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment beyond progression_EU CTR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Beyond_Progression | 2.0 ES |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Your rights as a subject in drug trials | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin_DE | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin_DE | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin_IE | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Carboplatin_IE | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin_IE | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cisplatin_PL | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ipilimumab | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nivolumab | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pemetrexed | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pemetrexed | NA |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DK_2023-503231-17_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NO_2023-503231-17_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG 2023-503231-17-00 Redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ES_Redacted | 5.0es |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis PL_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_Dutch 2023 503231 17_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_French 2023 503231 17_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_German 2023 503231 17_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2023-503231-17_EU CTR_Redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-503231-17_redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_Lay language_2023-503231-17_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LLS_BE-DE_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LLS_BE-FR_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LLS_BE-NL_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D4 Patient facing documents_Patient Reported Outcomes questionnaires NL_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D4_ Patient facing documents_9x questionnaires_NO_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_9x questionnaires_DK_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_9x questionnaries_IT_Italy_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_9x_FR_EU CTR_redacted | NA |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_9x_questionnaires_PL_Poland_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Patient Reported Outcomes questionnaires BE FR_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Patient Reported Outcomes questionnaires BE NL_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D4_Patient facing documents_Questionnaires_DE_German_redacted | NA |
| Synopsis of the protocol (for publication) | D4_patient-report-outcomes-ecog-pr | 1 |
| Synopsis of the protocol (for publication) | D4_patient-report-outcomes-justification statement | NA |
| Synopsis of the protocol (for publication) | D4_patient-report-outcomes-pgic-generic-cv1 | NA |
| Synopsis of the protocol (for publication) | D4_patient-report-outcomes-pgis-cancer | 1.0 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Denmark | Acceptable with conditions 2023-12-11
|
2023-12-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-08 | Denmark | Acceptable with conditions 2024-04-15
|
2024-04-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-19 | Denmark | Acceptable 2024-09-09
|
2024-09-11 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-13 | Denmark | Acceptable 2025-01-20
|
2025-01-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-10 | Acceptable | 2025-04-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-04 | Denmark | Acceptable | 2025-04-28 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-20 | Denmark | Acceptable 2025-08-13
|
2025-08-13 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-02 | Acceptable 2025-08-13
|
2025-09-02 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-04 | Acceptable 2025-08-13
|
2025-09-04 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-18 | Denmark | Acceptable 2025-10-30
|
2025-10-31 |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-13 | Denmark | Acceptable 2026-03-27
|
2026-03-27 |