Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
317
Countries
10
Sites
45
Non small cell lung cancer (NSCLC)
To compare the Progression Free Survival (PFS) per Blinded Independent Central Review (BICR) of repotrectinib and crizotinib
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Jan 2024 → ongoing
- Decision date (initial)
- 2024-01-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Bristol-Myers Squibb Services Unlimited Company
External identifiers
- EU CT number
- 2023-505604-32-00
- WHO UTN
- U1111-1292-0487
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Efficacy, Pharmacokinetic
To compare the Progression Free Survival (PFS) per Blinded Independent Central Review (BICR) of repotrectinib and crizotinib
Secondary objectives 6
- Overall Survival (OS) of repotrectinib and crizotinib
- Tumor response of repotrectinib and crizotinib
- PFS per investigator of repotrectinib and crizotinib
- Time to intracranial progression of repotrectinib and crizotinib
- Safety of repotrectinib and crizotinib
- Disease-related symptoms for repotrectinib and crizotinib
Conditions and MedDRA coding
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 | 10029521 | Non-small cell lung cancer stage IIIB | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Participant has histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC
- Participant has a ROS1 gene rearrangement/fusion as detected by a local test.
- At least 1 measurable lesion according to RECIST v1.1, as assessed by the investigator.
- Participants must not be exposed previously with TKIs that demonstrated activities in ROS1-positive NSCLC
- Up to 1 prior line of systemic treatment for NSCLC is permitted
- ECOG Performance Status ≤ 2
Exclusion criteria 4
- Symptomatic brain metastases or symptomatic leptomeningeal involvement.
- History of previous cancer requiring therapy within the previous 2 years, except for NSCLC under study, squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected.
- Known actionable tumor targetable co-mutations or rearrangements
- Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS per BICR, according to RECIST v1.1
Secondary endpoints 10
- Overall Survival
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Time to Response (TTR) per BICR and per investigator according to RECIST v1.1
- PFS per investigator according to RECIST v1.1
- Time to intracranial progression per BICR according to RECIST v1.1
- Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs)
- AEs leading to study intervention discontinuation
- Drug-related AEs and deaths
- Proportion of participants without meaningful symptom deterioration as measured by the NSCLC-SAQ total score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10161502 · Product
- Active substance
- Repotrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10501502 · Product
- Active substance
- Repotrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD672296 · Product
- Active substance
- Crizotinib
- Substance synonyms
- PF-02341066
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01ED01 — -
- Marketing authorisation
- EU/1/12/793/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD672297 · Product
- Active substance
- Crizotinib
- Substance synonyms
- PF-02341066
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01ED01 — -
- Marketing authorisation
- EU/1/12/793/004
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254 Blanchardstown Corporate Park 2, Ballycoolin Ballycoolin
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Y-Prime, Inc. ORL-000000955
|
Malvern, PA, United States | Other |
Locations
10 EU/EEA countries · 45 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 1 |
| France | Ongoing, recruitment ended | 19 | 8 |
| Germany | Ongoing, recruitment ended | 19 | 9 |
| Greece | Ended | 8 | 4 |
| Hungary | Ended | 2 | 1 |
| Italy | Ongoing, recruitment ended | 10 | 5 |
| Netherlands | Ended | 1 | 2 |
| Poland | Ended | 1 | 2 |
| Romania | Ongoing, recruitment ended | 10 | 5 |
| Spain | Ongoing, recruitment ended | 9 | 8 |
| Rest of world
Turkey, Korea, Democratic People's Republic of, Switzerland, India, Chile, Argentina, Brazil, China, United States, Canada
|
— | 234 | — |
Investigational sites
Krankenhaus Nord Klinik Floridsdorf
Internal Medicine and Pneumology, Bruenner Strasse 68, Floridsdorf, Vienna
Centre Hospitalier Universitaire De Nantes
oncology thoracic unit, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Les Hopitaux Universitaires De Strasbourg
pneumology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centr Georges Francois Leclerc
medical oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Universitaire De Bordeaux
respiratory medicine unit, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Paris
pneumology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire Grenoble Alpes
pneumology-thoracic oncology unit, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
CHU De Rouen
pneumology, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Lyon Sud
pulmonology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Asklepios Fachkliniken Muenchen Gauting
Onkologie, Robert-Koch-Allee 2, 82131, Gauting
Technische Universitat Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum Esslingen GmbH
Klinikum Esslingen, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Lungenfachklinik Immenhausen
Thoraxonkologie, Robert-Koch-Str. 3, 34376, Immenhausen
Pius-Hospital Oldenburg
Pius Hospital Oldenburg, Georgstrasse 12, Innenstadt, Oldenburg
Klinikum Wuerzburg Mitte gGmbH
Missionsärztliche Klinik, Salvatorstrasse 7, Frauenland, Wuerzburg
Marienhaus Kliniken GmbH
Klinik für Pneumologie, Beatmungs- und Schlafmedizin, An Der Goldgrube 11, Oberstadt, Mainz
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Klinik für Pneumologie, Lindenberger Weg 27, Buch, Berlin
University Hospital Cologne AöR
CIO / Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
University General Hospital Attikon
Research Unit, Rimini Street 1, 124 62, Athens
Theageneio Cancer Hospital
1st Department of Medical Oncology, Papanastassiou Alexandrou 11, 546 39, Thessaloniki
General University Hospital Of Patras
Division of Oncology, Rio, 265 04, Patras
Thoracic General Hospital Of Athens I Sotiria
3rd Internal Medicine Clinic, Messogion Avenue 152, 115 27, Athens
Koranyi National Institute For Pulmonology
Department of Pulmonology, Koranyi Frigyes Ut 1, 1121, Budapest XII
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica 2, Via Elio Chianesi N 53, 00144, Rome
Centro Di Riferimento Oncologico Di Aviano
UO Oncologia Medica, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Dei Colli
U.O.C. Oncologia, Via Leonardo Bianchi, 80131, Naples
Fondazione IRCCS San Gerardo Dei Tintori
S.C. Oncologia Medica, Via Giovanni Battista Pergolesi 33, 20900, Monza
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Universitair Medisch Centrum Groningen
Pulmonary Oncology, Hanzeplein 1, 9713 GZ, Groningen
Amsterdam UMC Stichting
Pulmonary Oncology, De Boelelaan 1117, 1081 HV, Amsterdam
Instytut Genetyki I Immunologii Genim Sp. z o.o.
N/A, Ul. Filaretow 27/2, 20-609, Lublin
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Oddzial Onkologii z Pododdzialem Chemioterapii, Ul. Jagiellonska Nr 78, 10-357, Olsztyn
Centrul De Oncologie-Euroclinic S.R.L.
Oncology, Strada Conta Vasile 2, 700106, Iasi
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul De Oncologie Monza S.R.L.
Oncology, Soseaua Ionescu-Sisesti Gheorghe 1, 013821, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Oncology, Soseaua Fundeni 252, 022328, Bucharest
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/n, 29010, Malaga
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-01-30 | 2025-09-22 | 2024-08-20 | 2025-05-15 | |
| France | 2024-01-26 | 2024-02-15 | 2025-05-15 | ||
| Germany | 2024-01-24 | 2024-03-14 | 2025-05-15 | ||
| Greece | 2024-04-05 | 2025-05-15 | 2025-01-09 | 2025-05-15 | |
| Hungary | 2024-08-08 | ||||
| Italy | 2024-02-13 | 2024-03-07 | 2025-05-15 | ||
| Netherlands | 2025-05-22 | 2025-09-05 | |||
| Poland | 2024-03-15 | 2025-05-15 | 2024-11-08 | 2025-05-15 | |
| Romania | 2024-01-26 | 2024-02-23 | 2025-05-15 | ||
| Spain | 2024-01-30 | 2024-02-22 | 2025-05-15 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-10-14
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-10-14
- Immediate action required
- Yes
- Notes
- Reverted (2025-10-14)
- Justification
- Dear Applicant,
It was ascertained that the Territorial Ethics Committee due to technical issue did not assess the documentation submitted for the SM-09 EU CT 2023-505604-32-00 procedure (AIFA authorization provision n° 0115112-12/09/2025-AIFA-AIFA_USC-P).
Therefore, in compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 112 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-505604-32-00 GR Redacted | 04 EU |
| Protocol (for publication) | D1_Protocol 2023-505604-32-00_Redacted | 04 EU |
| Protocol (for publication) | D1_Protocol administrative letter 2023-505604-32-00_Redacted | NA |
| Protocol (for publication) | D4 Patient Facing Documents redacted GR | NA |
| Protocol (for publication) | D4 Statement on validated questionnaire _under license PL | N/A |
| Protocol (for publication) | D4 statement_patient facing documents_AUT_GER_for publication | N/A |
| Protocol (for publication) | D4 statement_patient facing documents_D_GER_for publication | 1 |
| Protocol (for publication) | D4_Patient facing document_Questionnaire PGIC_AUT | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire PGIC_DE | 1 |
| Protocol (for publication) | D4_Patient facing document_Questionnaire PGIS_AUT | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire_PGIS_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents FACIT-GP5_IT_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents GP5_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents GP5_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PGIC_IT_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PGIC_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PGIC_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PGIS_IT_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PGIS_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PGIS_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents pro-ctcae_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PRO-CTCAE_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PROC_NSCLC-SAQ_IT_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PROC_NSCLC-SAQ_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents PROC_NSCLC-SAQ_Redacted | NA |
| Protocol (for publication) | D4_Patient facing documents_pro-ctcae_IT_Redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire PGIC_FR | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire PGIS_FR | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire PGIS_HU | 1 |
| Protocol (for publication) | D4_Patient facing documents_Statement on Questionnaires under licence ENG | 1 |
| Protocol (for publication) | D4_Patient facing documents_Statement on Questionnaires under licence_FR | N/A |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_HU | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_NL | 1 |
| Recruitment arrangements (for publication) | K1 Template recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_IT_Redacted | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_IT_tc | 2 |
| Recruitment arrangements (for publication) | K1_AT_recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements PL_Redacted | 2 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_DE | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_NL | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_redacted | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Generic Study Participant Guide Cancer | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Participant Guide Cancer_RO | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_ParticipantVisitPlanner_RO | NA |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Patient_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Patient_Brochure_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Generic Study Participant Guide Cancer_GR | NA |
| Recruitment arrangements (for publication) | K2_recruitment material_patient _translation | 1 |
| Recruitment arrangements (for publication) | K2_recruitment material_patient brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient brochure_translation | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient_Brochure_GR | 1.0 |
| Subject information and informed consent form (for publication) | L1 ICF for Pregnant Partners | 1.0 |
| Subject information and informed consent form (for publication) | L1 ICF for Treatment beyond Progression | 1.0 |
| Subject information and informed consent form (for publication) | L1 ICF Main Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Crossover | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF for Crossover study_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF for processing personal data_IT_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF MAIN _IT | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF TRAVEL REIMBURSEMENT _INSTITUTION_IT_tc | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ subject reimbourse_Administration_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_AT_ICF_PP_unredacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_ICF_TBP_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Crossover_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_AT_SIS and ICF Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF crossover IC_NLD Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Main_PL_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Patient Reimbursement _PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and IC Treatment Beyond Progression _PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_GR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Crossover_Redacted_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_DE_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_DE | 1 |
| 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 Pregnant partner_FR_Clean | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TBP_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF treatment beyond progression_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Crossover_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main IC_Included participant_FR_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main IC_New participant_FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main IC_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_NL_nld_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional IC_Crossover_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant and Pregnant Partner IC_NL_nld | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant_Partner_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_site contact details_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment beyond progression_Redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Xalkori Pfizer GmbH | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-505604-32_HU | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2023-505604-32-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-505604-32_NL | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-505604-32-00_FR | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2023-505604-32-00_AT | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2023-505604-32-00_ES | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2023-505604-32-00_GR | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2023-505604-32-00_RO | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2023-505604-32-00 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_EU CT 2023-505604-32-00 | 4 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-05 | France | Acceptable 2024-01-09
|
2024-01-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-17 | Acceptable 2024-01-09
|
2024-01-17 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-19 | Acceptable 2024-01-09
|
2024-01-19 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-01-22 | Acceptable 2024-01-09
|
2024-01-22 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-29 | |||
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-03-13 | France | 2024-03-13 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-08 | Acceptable | 2024-07-15 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-08 | France | Acceptable | 2024-04-23 |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-05-22 | Acceptable 2024-01-09
|
2024-08-02 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-08-09 | Acceptable 2024-01-09
|
2024-08-09 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-08-29 | France | Acceptable 2024-11-06
|
2024-11-06 |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-29 | France | Acceptable 2025-02-06
|
2025-02-06 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-04-09 | France | Acceptable 2025-02-06
|
2025-04-09 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-04-09 | Acceptable 2025-02-06
|
2025-04-09 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-07-11 | France | Acceptable 2025-09-01
|
2025-09-02 |
| 16 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-02-06 | France | Acceptable 2026-04-09
|
2026-04-10 |