Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruitment ended
Participants planned
616
Countries
6
Sites
40
Advanced or metastatic Non-small cell lung cancer (NSCLC)
To evaluate the efficacy of multiple therapies in patients with NSCLC selected according to results from the FoundationOne Liquid Companion Diagnostic (F1LCDx): alectinib (ALK+; RET+); entrectinib (ROS1+); atezolizumab (atezo) + cobimetinib (cobi) + vemurafenib (vem) (BRAF V600+); atezo + bevacizumab (bev) + carboplati…
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Aug 2017 → ongoing
- Decision date (initial)
- 2024-06-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
External identifiers
- EU CT number
- 2023-507500-31-00
- EudraCT number
- 2017-000076-28
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others, Dose response, Safety, Pharmacodynamic, Pharmacokinetic
To evaluate the efficacy of multiple therapies in patients with NSCLC selected according to results from the FoundationOne Liquid Companion Diagnostic (F1LCDx): alectinib (ALK+; RET+); entrectinib (ROS1+); atezolizumab (atezo) + cobimetinib (cobi) + vemurafenib (vem) (BRAF V600+); atezo + bevacizumab (bev) + carboplatin + pemetrexed (EGFR exon 20+) To evaluate the efficacy of atezo compared with platinum-based chemotherapy in treatment-naive patients with inoperable Stage IIIB or Stage IV NSCLC in patients who are blood tumor mutational burden positive according to F1LCDx (Cohort C)
Secondary objectives 5
- To evaluate the safety and tolerability of alectinib, atezo, entrectinib, atezo + cobi + vem, atezo + bev + carboplatin + pemetrexed, divarasib (Cohorts A-G). The efficacy of these drugs in patients with advanced or metastatic NSCLC as determined by the F1LCDx assay.
- Prognostic effect and pharmacodynamics of exploratory biomarkers in blood, and their association with disease status, mechanisms of resistance, and/or response to respective cohorts A-G
- To evaluate the pharmacokinetic (PK) characteristics of alectinib in RET+ patients (Cohort B), entrectinib in ROS1+ patients (Cohort D), atezo in BRAF V600+ patients (Cohort E) and in patients with EGFR exon 20+ advanced or metastatic NSCLC (Cohort F), and divarasib in KRAS G12C + patients (Cohort G)
- To evaluate the impact of study treatment on patient-reported outcome (PROs)
- To compare patients’ health status to generate utility scores for use in economic models for reimbursement (Cohorts A-F)
Conditions and MedDRA coding
Advanced or metastatic Non-small cell lung cancer (NSCLC)
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- N/A
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
- Measurable disease (as defined by RECIST, v1.1)
- Adequate recovery from most recent systemic or local treatment for cancer
- Adequate organ function
- Life expectancy >=12 weeks
- For female patients of childbearing potential and male patients, willingness to use acceptable methods of contraception
Exclusion criteria 6
- Inability to swallow oral medication
- Women who are pregnant or lactating
- Symptomatic, untreated CNS metastases Patients with treated and/or asymptomatic brain metastases may still be eligible for treatment on the study depending on individual cohort requirements; see the cohort-specific appendices for details regarding eligibility
- History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate ≥ 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ of breast, or Stage I uterine cancer
- Significant cardiovascular disease
- Known active or uncontrolled HIV infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- 1. Investigator-assessed ORR based on confirmed objective response (Cohorts A, B, D, and F)
- 2. Investigator-assessed PFS according to RECIST v1.1 (Cohort C) in bTMB the primary population of patients with a bTMB level equal to or greater than the higher validated cutoff (PP1)
- 3. Investigator-assessed 12-month time in response (TIR) per RECIST v1.1 (Cohort E)
- 4. Incidence, type, and severity of adverse events (based on the NCI CTCAE v5.0), (Cohorts G)
- 5. Change from baseline in targeted vital signs, clinical laboratory test results, ECG parameters (Cohorts G)
- 6. Tolerability of treatment as assessed through use of the NCI PRO-CTCAE (Cohort G) Frequency of patients' response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item EORTC Item List (IL46) (Cohort G)
Secondary endpoints 28
- 1. Investigator-assessed DOR, CBR, and PFS per RECIST v1.1 (Cohorts A, B, and D)
- 2. IRF-assessed ORR, DOR, CBR, and PFS per RECIST v1.1 (Cohorts A, B, and D)
- 3. IRF-assessed PFS, ORR, and DOR according to RECIST v1.1 (Cohort C and F)
- 4. Investigator-assessed ORR, and DOR according to RECIST v1.1 (Cohort C)
- 5. Investigator- and IRF-assessed time to CNS progression according to RECIST v1.1 (Cohort D)
- 6. OS (Cohorts A, B, D, E, and F)
- 7. Investigator-assessed PFS rates at 6-month and 1-year landmark timepoints (Cohort C)
- 8. Incidence, type, and severity of adverse events (based on the NCI CTCAE v4.0)(Cohorts A-F)
- 9. Changes in vital signs, physical findings, and clinical laboratory results during and following administration of protocol-specified IMPs (Cohorts A, B, D, E, and F)
- 10. DLTs, if any, associated with alectinib at escalating doses in RET+ patients (Cohort B)
- 11. PK parameters of alectinib in RET+ patients (Cohort B)
- 12. Population PK analysis for entrectinib (Cohort D)
- 13. Time to confirmed deterioration (TTCD) in patient-reported lung cancer symptoms of cough, dyspnea, and chest pain, as measured by the symptoms in lung cancer (SILC) (Cohort A, B, D, E, F)
- 14. Proportion of patients who improved compared with baseline in patient-reported lung cancer symptoms of cough, dyspnea, and chest pain and TTD as measured by SILC (Cohorts A, B, C, D, E, and F)
- 15. Proportion of patients presenting with measurable CNS disease at baseline who improve compared with baseline in patient-reported cognitive function, fatigue, health-related quality of life (HRQoL), headache, and vision disorder per the corresponding scales of the EORTC QLQ-C30 and BN20 (Cohort D)
- 16. Mean change from baseline in HRQoL, patient functioning, and symptoms as measured by the EORTC QLQ-C30, QLQ-LC-13 or SILC (Cohorts A, B, C, D, E, and F)
- 17. Health status as assessed by the EQ-5D-5L questionnaire (Cohorts A, B, C, D, E, and F)
- 18. Relationship between circulating biomarkers related to alectinib exposure and efficacy (Cohorts A and B), to atezolizumab efficacy (Cohort C) to entrectinib efficacy (Cohort D), atezo + cobi + vem efficacy (Cohort E), and atezo + bev + carboplatin + pemetrexed efficacy (Cohort F)
- 19. OS in bTMB PP1 (Cohort C)
- 20. Investigator-assessed PFS according to RECIST v1.1 in bTMB the secondary population of all patients who are bTMB-positive, which is the intent-to-treat (ITT) population in this cohort (PP2) [Cohort C]
- 21. OS in bTMB PP2 (Cohort C)
- 22. Investigator and IRF-assessed ORR, DOR, and PFS per RECIST v1.1 (Cohort E)
- 23. Investigator-assessed DOR and PFS per RECIST v1.1 (Cohort F)
- 24. 9-month TIR (Cohort E)
- 25. 12-month TIR (Cohort E)
- 26. Serum concentration of atezo at specified timepoints (Cohort E and F)
- 27. Presence of ADAs against atezo during the study relative to the presence of ADAs at baseline (Cohort E and F)
- 28. Plasma concentrations of divarasib at specified timepoints
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 17
—
PRD11081695 · Product
- Other product name
- GDC-6036
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD11081693 · Product
- Other product name
- GDC-6036
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD11081694 · Product
- Other product name
- GDC-6036
- Authorisation status
- Not Authorised
- MA holder
- GENENTECH, INC.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD5674603 · Product
- Authorisation status
- Not Authorised
- MA holder
- ROCHE REGISTRATION LTD.
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD9859689 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD801008 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD5956677 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/16/1169/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD10998730 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD10998736 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD10998728 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD10998729 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD975379 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD9910516 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD200064 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD10784718 · Product
- Other product name
- RO5514041
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD10777048 · Product
- Other product name
- RO5514041
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD2153902 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/04/300/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 8
—
PRD2433080 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD3445553 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/12/769/002
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SUB07892MIG · Substance
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD759858 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 39021.01.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD664576 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 44922.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD675076 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- PA 0749/004/001
- MA holder
- TEVA PHARMA B.V.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD674418 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- NL23774
- MA holder
- TEVA SANTÉ
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD415296 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- 34009 572 558 7 9
- MA holder
- ACCORD HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Foundation Medicine Inc. ORG-100040457
|
Boston, United States | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Exco Intouch Limited ORG-100040806
|
Nottingham, United Kingdom | E-data capture |
| Foundation Medicine GmbH ORG-100040499
|
Penzberg, Germany | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
Locations
6 EU/EEA countries · 40 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 3 |
| France | Ended | 90 | 2 |
| Germany | Ended | 16 | 3 |
| Italy | Ongoing, recruitment ended | 41 | 9 |
| Poland | Ongoing, recruitment ended | 40 | 6 |
| Spain | Ongoing, recruitment ended | 73 | 17 |
| Rest of world
Taiwan, Australia, Russian Federation, Japan, Argentina, Costa Rica, Singapore, Mexico, Hong Kong, Korea, Republic of, Peru, Canada, Tunisia, Brazil, Chile, Serbia, Israel, United States, Thailand, Turkey, Panama, New Zealand, China
|
— | 344 | — |
Investigational sites
UZ Brussel
Oncology, Laarbeeklaan 101, 1090, Jette
UZ Leuven
Respiratory Oncology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Assistance Publique Hopitaux De Paris
Pneumology, 4 Rue De La Chine, 75020, Paris
Centre Hospitalier Universitaire De Rennes
Pneumology, 2 Rue Henri Le Guilloux, 35000, Rennes
Klinikum Esslingen GmbH
KLINIK FÜR Kardiologie, Angiologie und Pneumologie, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Asklepios Klinik Gauting GmbH
Asklepios Fachkliniken München-Gauting Onkologie, Robert-Koch-Allee 2, 82131, Gauting
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Innere Medizin III: Hämatologie/Onkologie/ Palliativmedizin, Ludwig-Erhard-Strasse 100, Dotzheim, Wiesbaden
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Oncologia Medica, Piazza Oms 1, 24127, Bergamo
San Camillo Forlanini Hospital
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1, Circonvallazione Gianicolense 87, 00152, Rome
Azienda Socio Sanitaria Territoriale Di Cremona
ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona, Viale Concordia 1, 26100, Cremona
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
S.C.D.U. di Oncologia Toracica, Regione Gonzole 10, 10043, Orbassano
Centro Di Riferimento Oncologico Di Aviano
Irccs Centro Di Riferimento Oncologico (CRO), Via Franco Gallini 2, 33081, Aviano
European Institute Of Oncology S.r.l.
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Fondazione IRCCS San Gerardo Dei Tintori
ASST DI MONZA, Via Giovanni Battista Pergolesi 33, 20900, Monza
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Via Mariano Semmola 52, 80131, Naples
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddział Onkologii z Pododdziałem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
Oddział III - Chorób Płuc z Pododdziałem Onkologicznym, ul. Reymonta 83/91, 05-400, Otwock
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Oddział Onkologii z Pododdziałem Diagnostyki Nowotworów Klatki Piersiowej, Ul. Pradnicka 80, 31-202, Cracow
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Institut Catala D'oncologia
Oncología, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Regional De Malaga
Oncología, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Ramon Y Cajal
Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Oncología, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Clinico Universitario De Valencia
Oncología, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Virgen Del Rocio S.L.
Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complexo Hospitalario Universitario De Santiago
Oncología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Vall D Hebron
Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Hm Sanchinarro
Oncología, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Oncología, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Regional De Malaga
Oncología, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital General Universitario Gregorio Maranon
Oncología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Quironsalud Madrid
Oncología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario 12 De Octubre
Oncología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital General Universitario Dr. Balmis
Oncología, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Clinic De Barcelona
Oncología, Calle Villarroel 170, 08036, Barcelona
Hospital Germans Trias I Pujol
Oncología, Carretera Canyet 1a Planta, 08916, Badalona
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 | 2017-11-27 | 2024-12-31 | 2017-11-29 | 2024-09-23 | |
| France | 2018-01-22 | 2025-12-22 | 2018-02-01 | 2024-09-23 | |
| Germany | 2018-06-18 | 2024-09-24 | 2018-07-04 | 2024-09-23 | |
| Italy | 2017-10-05 | 2017-10-31 | 2024-09-23 | ||
| Poland | 2017-08-22 | 2017-08-29 | 2024-09-23 | ||
| Spain | 2017-08-25 | 2017-08-30 | 2024-09-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 37 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507500-31-00 Redacted.pdf | 9 |
| Protocol (for publication) | d4_patient-facing- documents_redaction-memo | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements placeholder | NA |
| Recruitment arrangements (for publication) | K2_Document_additionnel_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICC_PPA_Cohorts A-B | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF blood screening_File Note for outdated doc | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main cohort A_File Note for outdated doc | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main cohort C_REDACTED | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main cohort E_File Note for outdated doc | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main cohort G_REDACTED | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main crossover cohort G | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner cohort A and B_File Note for outdated doc | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner cohort C | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner cohort E_File Note for outdated doc | NA |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner cohort G | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF privacy consent form other subject | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Blood screening redacted | 12 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Cohort A | 8 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Cohort C redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Cohort D redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Cohort E redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RBR_All cohorts | 9 |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-carboplatin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-cisplatin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-docetaxel | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-gemcitabine | NA |
| Summary of Product Characteristics (SmPC) (for publication) | e2_smpc-pemetrexed | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507500-31-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE 2023-507500-31-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE-BE 2023-507500-31-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-507500-31-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-507500-31-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR-BE 2023-507500-31-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2023-507500-31-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL-BE 2023-507500-31-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2023-507500-31-00 | 2 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | Belgium | Acceptable 2024-06-10
|
2024-06-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-27 | Belgium | Acceptable 2024-06-10
|
2024-08-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-15 | Belgium | Acceptable 2025-01-28
|
2025-01-28 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-12 | Belgium | Acceptable 2025-01-28
|
2025-02-12 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-12 | Belgium | Acceptable 2025-01-28
|
2025-03-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-24 | Acceptable 2025-07-07
|
2025-07-09 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-21 | Acceptable 2025-11-03
|
2025-11-04 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-27 | Acceptable 2026-04-03
|
2026-04-07 |