Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,689
Countries
6
Sites
51
Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC)
"1. To demonstrate superiority of durvalumab + oleclumab relative to durvalumab + placebo in participants with unresectable, Stage III NSCLC who have not progressed on prior platinum-based cCRT •Assessment by PFS as assessed by BICR 2. To demonstrate superiority of durvalumab + monalizumab relative to durvalumab + plac…
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
- 1 Jun 2022 → ongoing
- Decision date (initial)
- 2024-02-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503999-24-00
- EudraCT number
- 2021-004346-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
"1. To demonstrate superiority of durvalumab + oleclumab relative to durvalumab + placebo in participants with unresectable, Stage III NSCLC who have not progressed on prior platinum-based cCRT
•Assessment by PFS as assessed by BICR
2. To demonstrate superiority of durvalumab + monalizumab relative to durvalumab + placebo in participants with unresectable, Stage III NSCLC who have not progressed on prior platinum-based cCRT
•Assessment by PFS as assessed by BICR"
Secondary objectives 1
- "To demonstrate superiority of durvalumab+oleclumab & durvalumab+monalizumab relative to durvalumab+placebo in patients with unresectable Stage III NSCLC who have not progressed on prior platinum-based cCRT; assessment by OS, OS24, ORR, DoR, PFS6, PFS12, PFS18, PFS24, PFS2, TTDM, TFST, PFS as assessed by Investigator To investigate relationship between patient’s PD-L1 expression on tumor cells & efficacy outcomes with durvalumab+oleclumab, durvalumab+monalizumab & durvalumab+placebo To assess PK of durvalumab when in combination with oleclumab & with monalizumab To assess PK of oleclumab when in combination with durvalumab To assess PK of monalizumab when in combination with durvalumab To investigate immunogenicity of durvalumab,oleclumab & monalizumab To assess time to deterioration in pulmonary symptoms"
Conditions and MedDRA coding
Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC)
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Part 1 Participants will undergo screening evaluations for tumour sample eligibility within 98 days prior to first treatment
|
Randomised Controlled | Double | [{"id":174621,"code":5,"name":"Carer"},{"id":174622,"code":4,"name":"Analyst"},{"id":174624,"code":3,"name":"Monitor"},{"id":174620,"code":2,"name":"Investigator"},{"id":174623,"code":1,"name":"Subject"}] | |
| 2 | Screening Part 2 Participants will undergo screening evaluations to determine eligibility within 42 days prior to first treatment
|
Randomised Controlled | Double | [{"id":174627,"code":2,"name":"Investigator"},{"id":174628,"code":1,"name":"Subject"},{"id":174626,"code":3,"name":"Monitor"},{"id":174629,"code":5,"name":"Carer"},{"id":174630,"code":4,"name":"Analyst"}] | |
| 3 | Treatment Participants will be randomised in a 1:1:1 ratio to one of the following intervention groups - experimental arm or control arm.
|
Randomised Controlled | Double | [{"id":174634,"code":2,"name":"Investigator"},{"id":174635,"code":5,"name":"Carer"},{"id":174633,"code":3,"name":"Monitor"},{"id":174636,"code":4,"name":"Analyst"},{"id":174632,"code":1,"name":"Subject"}] | Arm A: Arm A: durvalumab on Day 1 of each 28-day cycle + oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months (n = 333) Arm B: Arm B: durvalumab + monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only (n = 333) Arm C: Arm C: durvalumab on Day 1 of each 28-day cycle + placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months (n = 333) |
| 4 | Post-Treatment Follow up All participants will be followed up for safety assessments 00 days after their last dose of study intervention.
|
Randomised Controlled | Double | [{"id":174642,"code":4,"name":"Analyst"},{"id":174640,"code":5,"name":"Carer"},{"id":174638,"code":2,"name":"Investigator"},{"id":174639,"code":3,"name":"Monitor"},{"id":174641,"code":1,"name":"Subject"}] |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency, Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- "•Participant must be ≥ 18 years at the time of screening. •Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease •Provision of a tumour tissue sample obtained prior to CRT •Documented tumour PD-L1 status by central lab •Documented EGFR and ALK wild-type status (local or central). •Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy •Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy •Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique. •WHO performance status of 0 or 1 at randomization •Adequate organ and marrow function"
Exclusion criteria 1
- "•History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease. •Mixed small cell and non-small cell lung cancer histology. •Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. •Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. •Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia). •Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy. •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis – regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization. •Active or prior documented autoimmune or inflammatory disorders (with exceptions) •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab."
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1. Up to 5 years after first patient randomized.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651663 · Product
- Active substance
- Durvalumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC28 — -
- Marketing authorisation
- EU/1/18/1322/002
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC28 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10969991 · Product
- Active substance
- Oleclumab
- Substance synonyms
- MEDI9447
- Pharmaceutical form
- CONCENTRATE FOR 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
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10970031 · Product
- Active substance
- Monalizumab
- 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
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
SUB13981MIG · Substance
- Active substance
- Glucose
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 g/ml gram(s)/millilitre
- Max total dose
- 00 g/ml gram(s)/millilitre
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 g/ml gram(s)/millilitre
- Max total dose
- 00 g/ml gram(s)/millilitre
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- 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
6 EU/EEA countries · 51 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 52 | 12 |
| Germany | Ongoing, recruitment ended | 68 | 9 |
| Italy | Ongoing, recruitment ended | 32 | 8 |
| Poland | Ongoing, recruitment ended | 85 | 7 |
| Portugal | Ongoing, recruitment ended | 92 | 8 |
| Spain | Ongoing, recruitment ended | 108 | 7 |
| Rest of world
Japan, United States, Canada, Taiwan, China, Turkey, Vietnam, Thailand, Colombia, United Kingdom, Australia, Korea, Republic of, Peru, Brazil
|
— | 1,252 | — |
Investigational sites
Centre Hospitalier Intercommunal de Créteil
Service de Pneumologie, 40 Avenue De Verdun, 94000, Creteil
CHU Gabriel-Montpied
Service de Pneumologie, 58 Rue Montalembert, 63000, Clermont Ferrand
Assistance Publique Hopitaux De Marseille
Service Oncologie multidisciplinaire et innovations thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Sainte Catherine Institut Du Cancer Avignon-Provence
Département d'Oncologie Radiothérapie, 250 Chemin De Baigne Pieds, 84918, Avignon Cedex 9
Institut Gustave Roussy
Département d'Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
CHU De Bordeauxt
Service d'Oncologie Médicale, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
CHU De Rouen
Département de Pneumologie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Groupe Hospitalier Bretagne Sud
Service d'Oncologie Radiothérapie, 5 Avenue Etienne Francois De Choiseul, 56100, Lorient
Centre Hospitalier Universitaire De Toulouse
Service de Pneumologie, 24 Chemin De Pouvourville, 31400, Toulouse
CHU Rennes Pontchaillou Hospital
Service de Pneumologie, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Institut Regional Du Cancer De Montpellier
ICM Val d'Aurelle, 208 Avenue Des Apothicaires, 34090, Montpellier
Besancon University Hospital Center
Service de Pneumologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Pius-Hospital Oldenburg
Universitätsklinik für Innere Medizin – Onkologie, Klinik für Hämatologie und Onkologie, Georgstrasse 12, Innenstadt, Oldenburg
Klinikum Region Hannover GmbH
Klinik für Pneumologie, Intensiv- und Schlafmedizin, Stadionbruecke 4, Linden-Sued, Hanover
Onkodok GmbH
n/a, Brunnenstrasse 14, Innenstadt, Guetersloh
Franziskus Hospital Harderberg
Zentrum für Internistische Onkologie und Hämatologie, Alte Rothenfelder Strasse 23, Harderberg, Georgsmarienhuette
Universitaetsklinikum Essen AöR
Klinik und Poliklinik für Strahlentherapie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Wuerzburg AöR
n/a, Josef-Schneider-Strasse 11, Grombuehl, Wuerzburg
HELIOS Klinikum Erfurt GmbH
Klinik für Pneumologie, Schlaf- und Beatmungsmedizin, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
Klinikum Esslingen GmbH
n/a, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Universitaetsklinikum Erlangen AöR
Strahlenklinik, Universitaetsstrasse 27, Innenstadt, Erlangen
Careggi University Hospital
Radioterapia Oncologica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Struttura Semplice Dipartimentale di Oncologia Toracica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Dipartimento di Oncologia ASL 2, Via Filippo Francesconi 556, 55100, Lucca
Azienda Ospedaliero Universitaria Parma
Struttura complessa Oncologia medica, Viale Antonio Gramsci 14, 43126, Parma
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Unità Oncologica Toracica, Regione Gonzole 10, 10043, Orbassano
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Radioterapia Oncologica, Piazzale Spedali Civili 1, 25123, Brescia
Fondazione IRCCS Policlinico San Matteo
UOC Oncologia, Viale Camillo Golgi 19, 27100, Pavia
Fondazione Policlinico Universitario Campus Bio-Medico
Radioterapia Oncologica, Via Alvaro Del Portillo N 200, 00128, Rome
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
n/a, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
n/a, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
NA, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
Uniwersyteckie Centrum Kliniczne
n/a, Ul. Debinki 7, 80-952, Gdansk
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
n/a, Ul. Tytusa Chalubinskiego 7, 75-581, Koszalin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
n/a, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
n/a, Ul. Ksiecia Jozefa Poniatowskiego 26, 08-110, Siedlce
Hospital Cuf Descobertas S.A.
Oncology Department, Rua Mario Botas 1, 1998-018, Lisbon
Unidade Local De Saude De Santa Maria E.P.E.
Oncological Pneumology, Alameda Das Linhas De Torres No 117, 1769-001, Lisbon
Unidade Local de Saude de Sao Joao E.P.E.
Pneumology, Alameda Professor Hernani Monteiro, 4200-319, Porto
Champalimaud Clinical Centre
Pneumology, Avenida Brasilia S/n, 1400-038, Lisbon
Galo Saude Parcerias Cascais S.A.
Serviço de Oncologia, Avenida Brigadeiro Victor Novais Goncalves, Cobre, Cascais
Unidade Local De Saude De Coimbra E.P.E.
Serviço de Pneumologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Pneumology, Rua Professor Lima Basto, 1099-023, Lisbon
Unidade Local De Saude De Loures-Odivelas EPE
Oncology Departement, Avenida Carlos Teixeira 3, 2674-514, Loures
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
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 |
|---|---|---|---|---|---|
| France | 2022-09-14 | 2022-09-21 | 2025-06-12 | ||
| Germany | 2022-08-26 | 2022-09-29 | 2025-06-05 | ||
| Italy | 2022-07-29 | 2022-09-07 | 2025-05-29 | ||
| Poland | 2022-09-09 | 2022-09-15 | 2025-06-13 | ||
| Portugal | 2023-07-26 | 2023-11-07 | 2025-06-18 | ||
| Spain | 2022-06-01 | 2022-08-04 | 2025-06-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 86 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol synopsis CTD_FR_EU CTR 2023-503999-24-00_redacted_15_05_2023 | 2.1 |
| Protocol (for publication) | D1_ Protocol synopsis_FR_EU CTR_ 2023-503999-24-00_redacted | 2 |
| Protocol (for publication) | D1_Protocol 2023-503999-24-00_Redacted | 4 |
| Protocol (for publication) | D1_Protocol Addendum_Redacted | 2 |
| Protocol (for publication) | D1_Protocol synopsis Lay Language_ES_Redacted | 2 |
| Protocol (for publication) | D1_Protocol Synopsis_2023-503999-24 redacted | 2 |
| Protocol (for publication) | D1_Protocol Synopsis_IT_Lay language_2023-503999-24-00_redacted | 2 |
| Protocol (for publication) | D1_Protocol synopsis_lay language_PL_Redacted | 2 |
| Protocol (for publication) | D3_Data Safety Monitoring Committee Charter_2023-503999-24 redacted | n/a |
| Protocol (for publication) | D3_Data Safety Monitoring Committee Charter_Addendum 2023-503999-24 redacted | n/a |
| Protocol (for publication) | D4_ Patient facing documents French Questionnaire NSCLC-SAQ_V1_2015_FOR PUBLICATION | 1 |
| Protocol (for publication) | D4_Patient facing document_NSCLC-SAQ questionnaire PT_FOR PUBLICATION | n/a |
| Protocol (for publication) | D4_Patient facing documents ES PROC_NSCLC-SAQ_FOR PUBLICATION | n/a |
| Protocol (for publication) | D4_Patient facing documents_1x questionnaries_IT_Italy_redacted | n/a |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-guidance-letter-redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-nsclc-guidance-letter-redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-pac-9-ecard-redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-pac-9-fug-redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-pac-9-hcp-ref-let-redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-poster-charting-new-course-nsclc | 1 |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-study-participation-cards-v1 | 1 |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-thank-you-cards | 1 |
| Protocol (for publication) | D4_Patient facing documents_2023-503999-24-unblinded-cards-redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_NSCLC-SAQ questionnair_PL_Poland_Redacted | n/a |
| Protocol (for publication) | D4_Patient facing documents_NSCLC-SAQ questionnaire_DE_German_redacted | 1 |
| Protocol (for publication) | Protocol Placeholder | NA |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | CTIS Blank Document for Transition Trials | n/a |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangement_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement and Material PT_redacted | n/a |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Germany | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Pamphlet_DE_German_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Poster_DE_German | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ecard_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FUG_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HCPRefLet_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pamphlet_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PSG_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PSTR | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangement Placeholder | NA |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult Part I PL_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult Part II PL_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults Part I_EU CTR_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults Part II_EU CTR_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF genetic PL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Genetic_EU CTR_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_EU CTR_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partners PL_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adult Subject_Part I_Redacted | 4.0 ES |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Adult Subject_Part II_Redacted | 6.0 ES |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Annex to Adult Subject_Part II_Redacted | 6.0 ES |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Genetic Subject_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Subject German_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Subject Screening Part I German_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for adult_part I_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for adult_part II_redacted | 7 |
| 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_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research German_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research German_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partners German_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PT Adult Part2_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PT Adulto Part2_Redacted | 6.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PT Adulto Part2_v4_2_Redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PT Genetic_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PT Master Screen Part1_Redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PT Pregnant Participant_Redacted | 0.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PT Pregnant Partner_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Study Information n1_Part II_FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | Subject Information and Informed Consent Form Placeholder | NA |
| Subject information and informed consent form (for publication) | Subject Information and Informed Consent Form Placeholder | NA |
| Subject information and informed consent form (for publication) | Subject Information and Informed Consent Form Placeholder | NA |
| Subject information and informed consent form (for publication) | Subject Information and Informed Consent Form Placeholder | NA |
| Subject information and informed consent form (for publication) | Subject Information and Informed Consent Form Placeholder | NA |
| Synopsis of the protocol (for publication) | D1_Protocol LL synopsis PT 2023-503999-24-00_ Redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific synopsis PT 2023-503999-24-00_redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis _ES_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-503999-24-00_redacted | 3 |
| Synopsis of the protocol (for publication) | Synopsis of the Protocol Placeholder | NA |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-14 | Spain | Acceptable 2024-02-13
|
2024-02-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-14 | Spain | Acceptable 2024-06-05
|
2024-06-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-09 | Spain | Acceptable 2024-09-11
|
2024-09-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-28 | Spain | Acceptable 2025-02-14
|
2025-02-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-21 | Acceptable | 2025-03-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-22 | Acceptable | 2025-05-13 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-27 | Acceptable | 2025-07-30 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-30 | Acceptable | 2025-09-30 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-03 | Acceptable | 2025-10-03 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-15 | Spain | Acceptable | 2025-10-15 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-21 | Acceptable | 2025-11-17 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-03-04 | Acceptable | 2026-03-24 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-03-04 | Spain | Acceptable | 2026-04-01 |
| 14 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-03-04 | Acceptable | 2026-03-20 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-03-04 | Acceptable | 2026-04-14 |