Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
150
Countries
8
Sites
31
Resectable Stage I-III Non-Small Cell Lung Cancer (NSCLC)
The objective of this study was to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Following the study’s early closure, the objectives for cohort B1 have changed. The objectives for cohort B2 remain unchanged as no participants were enrolled in that cohort or are…
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
- 5 May 2025 → ongoing
- Decision date (initial)
- 2025-03-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- F. Hoffmann-La Roche AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Pharmacokinetic, Safety, Efficacy
The objective of this study was to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Following the study’s early closure, the objectives for cohort B1 have changed. The objectives for cohort B2 remain unchanged as no participants were enrolled in that cohort or are planned to be enrolled in that cohort. Cohort B1: To explore the safety of alectinib in combination with chemotherapy in patients with completely resected Stage II, IIIA, and selected IIIB (T3N2 only; as per AJCC eighth edition), anaplastic lymphoma kinase (ALK)-positive NSCLC Cohort B2:To evaluate the efficacy of neoadjuvant treatment with alectinib in combination with chemotherapy in patients with resectable Stage II, IIIA, and selected IIIB (T3N2 only; as per AJCC, Eighth Edition), ALK-positive NSCLC
Secondary objectives 6
- Cohort B1: To explore the safety of alectinib in combination with chemotherapy followed by alectinib monotherapy in patients with completely resected Stage II, IIIA, and selected IIIB (T3N2 only; AJCC eighth edition), ALK positive NSCLC
- Cohort B2: To evaluate the efficacy of neoadjuvant treatment with alectinib in combination with chemotherapy in patients with resectable Stage II, IIIA, and selected IIIB (T3N2 only; AJCC Eighth Edition), ALK-positive NSCLC
- Cohort B2: To evaluate the efficacy of neoadjuvant treatment with alectinib in combination with chemotherapy, followed by adjuvant treatment with alectinib monotherapy in patients with resectable Stage II, IIIA, and selected IIIB (T3N2 only; AJCC Eighth Edition), ALK-positive NSCLC
- Cohort B2: To evaluate the safety of neoadjuvant treatment with alectinib in combination with chemotherapy, followed by adjuvant treatment with alectinib monotherapy in patients with resectable Stage II, IIIA, and selected IIIB (T3N2 only; AJCC Eighth Edition), ALK-positive NSCLC
- Cohort B2: To evaluate the safety and feasibility of surgery after neoadjuvant treatment with alectinib in combination with chemotherapy in patients with resectable Stage II, IIIA, and selected IIIB (T3N2 only; AJCC Eighth Edition), ALK-positive NSCLC
- Cohort B2: To document efficacy and tolerability of neoadjuvant alectinib combined with chemotherapy, followed by adjuvant alectinib monotherapy in terms of quality of life and daily function in patients with completely resected Stage II, IIIA, and selected IIIB (T3N2 only; AJCC Eighth Edition), ALK-positive NSCLC
Conditions and MedDRA coding
Resectable Stage I-III Non-Small Cell Lung Cancer (NSCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
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
- Cohort B1: Complete resection of the primary NSCLC with negative margins
- Cohort B1: Confirmed stage II-select IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology
- Cohort B1: ECOG performance status of 0 or 1
- Cohort B2: Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
- Cohort B2: Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology
- Cohort B1 and B2: Documented ALK fusion
Exclusion criteria 6
- Cohort B1: NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
- Cohort B1 and B2: Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Cohort B1: Prior exposure to any systemic anti-cancer therapy
- Cohort B2: Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection
- Cohort B2: Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin
- Cohort B1:Prior exposure to any systemic anti-cancer therapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 1. Cohort B1: Incidence, type, and severity of adverse events with onset up to 28 days after the last dose of chemotherapy treatment according to NCI CTCAE v5.0.
- 2. Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)
Secondary endpoints 11
- 1. Cohort B1:Incidence, type, and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5 (NCI CTCAE v5.0). Adverse Events with onset up to 28 days after the last dose of study treatment, or until last on site/discontinuation visit, whichever comes first
- 2. Cohort B2:Investigator-assessed major pathological response (inv-MPR)
- 3. Cohort B2: Pathologic complete response (pCR) by independent review
- 4. Cohort B2: Major pathologic response (MPR) by independent review
- 5. Cohort B2: Investigator-assessed overall response rate (ORR) per RECIST v1.1
- 6. Cohort B2: Investigator-assessed event-free survival (EFS)
- 7. Cohort B2: OS
- 8. Cohort B2: Incidence, severity and type of AEs, with severity determined through use of NCI CTCAE v5.0
- 9. Cohort B2: Change from baseline in target safety parameters (vital signs, clinical laboratory test results, ECG parameters)
- 10. Cohort B2: Frequency of surgery completion, defined as patients who have successfully completed surgery without treatment related delays (> 60 days) from the last dose of neoadjuvant treatment
- 11. Cohort B2: Length of treatment related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
PRD9859689 · Product
- Active substance
- Alectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 876 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD5956678 · Product
- Active substance
- Alectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 876 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01ED03 — -
- Marketing authorisation
- EU/1/16/1169/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Pfizer 25 mg/ml concentrate for solution for infusion.
PRD8396779 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1057/005
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
PRD8505444 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1071/005
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2000 gm/m2 gram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion
PRD7936183 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/16/1115/004
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
CARBOPLATINE ACCORD 10 mg/ml, solution pour perfusion
PRD415296 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- 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
Carboplatin Bendalis 10mg/ml, Konzentrat zur Herstellung einer Infusionslösung
PRD2832939 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 86830.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
CARBO-cell® 10 mg/ml Infusionslösung, Konzentrat zur Herstellung einer Infusionslösung
PRD1969079 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 46297.00.00
- MA holder
- STADAPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD11854707 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 84223.00.00
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- relabeled for clinical trial use
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 39021.01.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD9682731 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 2205259.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
Cisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD662245 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 71983.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-packaging and re-labelling for clinical trial use
CISPLATINE ACCORD 1 mg/ml, solution à diluer pour perfusion
PRD415238 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 34009 579 377 8 2
- 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 12
| Organisation | City, country | Duties |
|---|---|---|
| Axon Communications Inc. ORG-100048038
|
Toronto, Canada | Laboratory analysis |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Laboratory analysis |
| Median Technologies ORG-100041462
|
Valbonne, France | Laboratory analysis |
| Almac Group Limited ORG-100011829
|
Craigavon, United Kingdom (Northern Ireland) | Other |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Laboratory analysis |
| Kayentis ORG-100037894
|
Meylan, France | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Q Squared Solutions (Beijing) Co. Ltd. ORG-100043283
|
Beijing, China | Laboratory analysis |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Laboratory analysis |
| Q2q Communications Limited ORG-100041455
|
Richmond, United Kingdom | Other |
Locations
8 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 1 |
| Belgium | Ended | 2 | 2 |
| Denmark | Ended | 3 | 1 |
| France | Ended | 15 | 8 |
| Italy | Ongoing, recruitment ended | 10 | 8 |
| Netherlands | Ended | 4 | 1 |
| Poland | Ended | 9 | 5 |
| Spain | Ended | 7 | 5 |
| Rest of world
Australia, Korea, Republic of, Chile, China, United Kingdom, Brazil, Thailand, Mexico, New Zealand, United States
|
— | 96 | — |
Investigational sites
Stadt Wien Wiener Gesundheitsverbund
Department for Respiratory and Critical Care Medicine, Bruenner Strasse 68, Floridsdorf, Vienna
UZ Leuven
Respiratory Oncology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Medical oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Rigshospitalet
Onkologisk afdeling, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Intercommunal De Cornouaille
pneumology oncology, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Centre Francois Baclesse
Oncologie, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Les Hopitaux Universitaires De Strasbourg
Pneumology department, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Hospices Civils De Lyon
Pulmonology, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Centre Leon Berard
Department of Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Thoracy oncology unit, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Regional De Marseille
CEPCM, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Bordeaux
Pneumology, Avenue De Magellan, 33600, Pessac
Cliniche Gavazzeni S.p.A.
Oncologia Medica, Via Mauro Gavazzeni 21, 24125, Bergamo
ASST Grande Ospedale Metropolitano Niguarda
Ematologia ed Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Istituto Oncologico Veneto
Oncologia Medica, Via Gattamelata 64, 35128, Padova
Istituto Europeo Di Oncologia S.r.l.
Oncologia, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Tumori Bari Giovanni Paolo II
Oncologia, Viale Orazio Flacco 65, 70124, Bari
Hospital Santa Maria Della Misericordia
Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Amsterdam UMC Stichting
Lung Diseases, De Boelelaan 1117, 1081 HV, Amsterdam
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii, Ul. Augustyna Szamarzewskiego 62, 60-569, Poznan
Centrum Pulmonologii I Torakochirurgii W Bystrej
Oddział Pulmonologiczno-Onkologiczny z Chemioterapią, Ul. Juliana Falata 2, Bystra, Wilkowice
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Płuca i Klatki Piersiowej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Oddział Onkologii Klinicznej, Ul. Grabiszynska 105, 53-439, Wroclaw
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, 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 |
|---|---|---|---|---|---|
| France | 2025-06-22 | ||||
| Italy | 2025-05-14 | 2025-06-06 | 2025-10-02 | ||
| Poland | 2025-07-31 | ||||
| Spain | 2025-05-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 90 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_protocol-2024-511239-91-00-redacted | 2 |
| Protocol (for publication) | d4_patient-facing-documents_memo | N/A |
| Protocol (for publication) | d4_patient-facing-documents_Study Medication Diary Cohort_Army B1 and B2_redaction memo | 2 |
| Protocol (for publication) | d4_patient-facing-documents_Study Medication Diary Cohort_Army B1 B2_redaction memo | 2 |
| Recruitment arrangements (for publication) | K1_Document additionnel_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangements | 6 |
| Recruitment arrangements (for publication) | K1_RecruitmentArrangements_AT | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material Clinical Trial Leaflet | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material Is a clinical research study right for me | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material QR code_ Is a clinical research study right for me | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material Storyboard | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material What is a Clinical Research Study | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_communication to doctors | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 1 |
| Subject information and informed consent form (for publication) | L1_Appendix I - GDPR | 1 |
| Subject information and informed consent form (for publication) | L1_Genome research - The Right to Not Know | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Infant Health | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Mobile nursing | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Optional RBR | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subject | NA |
| Subject information and informed consent form (for publication) | L1_Recruitment Arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF_NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF infant and Privacy sheet | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Infant Authorization | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort B1 Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort B1 redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort B1_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort B1_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main Cohort B1_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort B2 Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main Cohort B2 redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort B2_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Cohort B2_REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main Cohort B2_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN ICF Cohort B1_EN_redacted | v2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN ICF Cohort B1_FR_redacted | v2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN ICF Cohort B1_NL_redacted | v2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN ICF Cohort B2_EN_redacted | v2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN ICF Cohort B2_FR_redacted | v2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF MAIN ICF Cohort B2_NL_redacted | v2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PAP | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 2 |
| Subject information and informed consent form (for publication) | L1_SISandICF_IAF_AT | 1.0 |
| Subject information and informed consent form (for publication) | L1_SISandICF_Main_AT_Cohort B1_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SISandICF_Main_AT_Cohort B2_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SISandICF_optional RBR_AT | 1.0 |
| Subject information and informed consent form (for publication) | L1_SISandICF_PPA_AT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Informed_Consent_Form_Procedure | 3 |
| Subject information and informed consent form (for publication) | L2_Sponsor Statement On Use Of ICF Model | 1 |
| Subject information and informed consent form (for publication) | L2_Your Rights as a Trial Participant | 1 |
| 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-pemetrexed | NA |
| Summary of Product Characteristics (SmPC) (for publication) | parti-products-e2_smpc-alecensa.pdf | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_AT-DE 2024-511239-91-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_BE-DE 2024-511239-91-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_BE-FR 2024-511239-91-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_BE-NL 2024-511239-91-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2024-511239-91-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_ES 2024-511239-91-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_FR-FR 2024-511239-91-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_IT 2024-511239-91-00 | 2.0 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_NL 2024-511239-91-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_PL 2024-511239-91-00 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-25 | Belgium | Acceptable with conditions 2025-03-03
|
2025-03-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-07 | Acceptable with conditions 2025-03-03
|
2025-04-07 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-10 | Belgium | Acceptable with conditions 2025-03-03
|
2025-11-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-19 | Acceptable 2026-04-28
|
2026-04-30 |