Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
206
Countries
10
Sites
43
Non-small cell lung cancer with ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene rearrangements
To evaluate the efficacy of entrectinib compared with crizotinib in patients who have ROS1 rearrangement-positive NSCLC with CNS metastases at baseline
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
- 24 Sep 2021 → ongoing
- Decision date (initial)
- 2024-02-20
- 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
- 2023-507494-18-00
- EudraCT number
- 2019-003859-11
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Others, Safety
To evaluate the efficacy of entrectinib compared with crizotinib in patients who have ROS1 rearrangement-positive NSCLC with CNS metastases at baseline
Secondary objectives 4
- To evaluate the efficacy of entrectinib compared with crizotinib in patients who have ROS1 rearrangement-positive NSCLC in the whole study population (ITT)
- To evaluate the efficacy of entrectinib compared with crizotinib in patients who have ROS1 rearrangement-positive NSCLC with CNS metastases at baseline
- To evaluate the safety of entrectinib compared with crizotinib in patients who have ROS1 rearrangement-positive NSCLC
- To evaluate health status utility scores of patients treated with entrectinib to inform pharmacoeconomic modeling using the the EuroQol 5-Dimension Questionnaire (5-level version; EQ-5D-5L) index-based and Visual Analog Scale scores
Conditions and MedDRA coding
Non-small cell lung cancer with ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene rearrangements
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Period 28-day screening period
|
Not Applicable | None | ||
| 2 | Treatment Period Open-label treatment with either entrectinib or crizotinib
|
Randomised Controlled | None | Experimental Arm: Entrectinib (experimental arm) Control Arm: Crizotinib (control arm) |
|
| 3 | Follow-Up Period Post-Treatment Visit and Follow-Up Period
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Histologically or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement
- No prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC
- Prior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomization
- Measurable systemic disease according to RECIST v1.1
- Participants with measurable and non-measurable CNS lesions per RECIST v1.1, including leptomeningeal carcinomatosis
- Life expectancy of at least 12 weeks
Exclusion criteria 6
- Prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC
- NCI-CTCAE v5.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia, fatigue, nausea and lack of appetite), which have not shown improvement and are strictly considered to interfere with current study drug
- History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤ 50% observed during screening for the study
- History of prolonged corrected QTc interval
- Peripheral sensory neuropathy ≥ Grade 2
- Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Progression-free survival (PFS) in patients with CNS metastases at baseline, defined as the time from randomization to the first documented disease progression (extracranial or intracranial) or death from any cause, whichever occurs first, as determined by a blinded independent review committee (BIRC) using RECIST v1.1
Secondary endpoints 11
- 1. Progression-free survival in the CNS (CNS-PFS), defined as the time from randomization to the first documented disease progression in the CNS or death from any cause, whichever occurs first, as determined by the BIRC using RECIST v1.1
- 2. Overall response rate (ORR), defined as the percentage of patients who attain CR or PR, as assessed by the BIRC and the investigator per RECIST v1.1
- 3. Duration of response (DOR), defined as the time from when response (CR or PR) is first documented to disease progression or death, whichever occurs first, as assessed by the BIRC and the investigator per RECIST v1.1
- 4. Progression-free survival (PFS), defined as the time from randomization to the first documented disease progression (extracranial or intracranial) or death from any cause, whichever occurs first, as determined by the BICR and investigator using RECIST v1.1
- 5. Overall survival (OS), defined as the time from randomization to death from any cause
- 6. Impact on functioning, including health-related quality of life, using the Global Health Status/Quality of Life (GHS/QoL), the Physical Functioning (PF) and Role Function (RF) scores, as assessed by the EORTC QLQ-C30 and analyzed as a time to first and confirmed clinically meaningful deterioration
- 7. Impact on lung cancer-specific symptoms, as assessed by the EORTC QLQ-LC13
- 8. Objective response rate in the CNS (CNS-ORR), defined as the percentage of patients who attain CR or PR for lesions in the CNS, as determined by the BICR per RECIST v1.1
- 9. Duration of response in the CNS (CNS-DOR), defined as the time from when a CNS response (CR or PR) is first documented to disease progression in the CNS, as determined by the BICR per RECIST v1.1
- 10. Incidence, type, timing, relatedness and severity of adverse events , including serious adverse events and adverse events leading to dose modifications/interruptions, study drug withdrawal or death, as assessed by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
- 11. Health utility from the EQ-5D-5L and pharmacoeconomic model
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
PRD11011283 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998729 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Rozlytrek 100 mg hard capsules
PRD8236780 · Product
- Active substance
- Entrectinib
- Substance synonyms
- NMS-1191372, N-[5-(3,5-DIFLUOROBENZYL)-1H-INDAZOL-3-YL]-4-(4 METHYLPIPERAZIN-1-YL)-2-(TETRAHYDRO-2H-PYRAN-4-YLAMINO)BENZAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EX14 — -
- Marketing authorisation
- EU/1/20/1460/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeled and re packaged for Clinical Trial Use
PRD10998736 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998732 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998730 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Rozlytrek 200 mg hard capsules
PRD8236731 · Product
- Active substance
- Entrectinib
- Substance synonyms
- NMS-1191372, N-[5-(3,5-DIFLUOROBENZYL)-1H-INDAZOL-3-YL]-4-(4 METHYLPIPERAZIN-1-YL)-2-(TETRAHYDRO-2H-PYRAN-4-YLAMINO)BENZAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EX14 — -
- Marketing authorisation
- EU/1/20/1460/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labeled and re packaged for Clinical Trial Use
PRD10998735 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998733 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998731 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998734 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10998728 · Product
- Active substance
- Entrectinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1516 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 4
PRD3362134 · Product
- Active substance
- Crizotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 1263 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01ED01 — -
- Marketing authorisation
- EU/1/12/793/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labelled for clinical trial use
PRD3362139 · Product
- Active substance
- Crizotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 1263 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01ED01 — -
- Marketing authorisation
- EU/1/12/793/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Re-labelled for clinical trial use
PRD3362133 · Product
- Active substance
- Crizotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 1263 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01ED01 — -
- Marketing authorisation
- EU/1/12/793/004
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling for clinical trial use
PRD3362138 · Product
- Active substance
- Crizotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 1263 g gram(s)
- Max treatment duration
- 361 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01ED01 — -
- Marketing authorisation
- EU/1/12/793/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Relabeling for clinical trial use
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 7
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Code 10 |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Code 5 |
| Almac ORG-100013160
|
Souderton, United States | Interactive response technologies (IRT) |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Other |
Locations
10 EU/EEA countries · 43 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Croatia | Ongoing, recruitment ended | 3 | 1 |
| France | Ongoing, recruitment ended | 14 | 7 |
| Germany | Ongoing, recruitment ended | 10 | 5 |
| Greece | Ongoing, recruitment ended | 5 | 4 |
| Italy | Ongoing, recruitment ended | 14 | 9 |
| Netherlands | Ongoing, recruitment ended | 12 | 3 |
| Romania | Ongoing, recruitment ended | 8 | 6 |
| Slovakia | Ongoing, recruitment ended | 5 | 2 |
| Spain | Ongoing, recruitment ended | 16 | 5 |
| Sweden | Ongoing, recruitment ended | 4 | 1 |
| Rest of world
Thailand, Lebanon, Turkey, Mexico, Jordan, India, Brazil, Russian Federation, China
|
— | 115 | — |
Investigational sites
KBC Zagreb
Department of Pulmonary Diseases, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Assistance Publique Hopitaux De Marseille
Cancérologie-pneumologie, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire De Toulouse
Cancérologie-pneumologie, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Leon Berard
Cancérologie-pneumologie, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Cancérologie-pneumologie, 229 Cours De L Argonne, 33000, Bordeaux
Centre Hospitalier Universitaire De Lille
Cancérologie-pneumologie, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hopitaux Prives De Metz
Cancérologie-pneumologie, Parvis Schuman Rue Champs Montoy, Rue Pre Montois, Vantoux
Centre Hospitalier Universitaire De Rennes
Cancérologie-pneumologie, 2 Rue Henri Le Guilloux, 35000, Rennes
HELIOS Klinikum Emil von Behring GmbH
Pneumologie Onkologie u.Infektiologie, Walterhoeferstrasse 11, Zehlendorf, Berlin
Kliniken Maria Hilf GmbH Moenchengladbach
Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus, Viersener Strasse 450, Windberg, Moenchengladbach
University Medical Center Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf; Med. II. Klinik, Martinistrasse 52, Eppendorf, Hamburg
Pius-Hospital Oldenburg
Haematologie und Onkologie, Georgstrasse 12, Innenstadt, Oldenburg
Justus-Liebig-Universitaet Giessen
Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V, Klinikstrasse 33, 35392, Giessen
Euromedica General Clinic Of Thessaloniki
Oncology Department, Kallas Marias 11, Gravias 2, Thessaloniki
General University Hospital Of Larissa
Medical Oncology, P. O. Box 1425, 411 10, Larissa
Thoracic General Hospital Of Athens I Sotiria
3rd Dept. of Internal Medicine, Oncology Unit, Messogion Avenue 152, 115 27, Athens
Metropolitan Hospital
4th Oncology department, Ethnarchi Makariou 11, 185 47, Pireas
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento Di Ematologia Ed Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Dipartimento di Oncologia, Regione Gonzole 10, 10043, Orbassano
San Camillo Forlanini Hospital
U.O.C. Pneumologia Ad Indirizzo Oncologico 1, Circonvallazione Gianicolense 87, 00152, Rome
Fondazione IRCCS San Gerardo Dei Tintori
S.C. Oncologia Medica S.S. Lung Unit, Via Giovanni Battista Pergolesi 33, 20900, Monza
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncologia Clinica Sperimentale Toraco-Polmonare, Via Mariano Semmola 52, 80131, Naples
IRCCS Ospedale Policlinico San Martino
Clinica di Oncologia Medica, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Oncologico Veneto
Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero Universitaria Pisana
UP Pneumologia, Via Roma 67, 56126, Pisa
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica B, Via Elio Chianesi N 53, 00144, Rome
Radboud universitair medisch centrum / RADBOUDUMC
Lung Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Long Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Long Oncologie, Plesmanlaan 121, 1066 CX, Amsterdam
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Radiotherapy Center Cluj S.R.L.
Oncology, Str. Razoare Nr. 486g Jud. Cluj, 407280, Floresti
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Municipal Ploiesti
Oncology, Strada Ipatescu Ana Nr 59, 100337, Ploiesti
Institutul Regional De Oncologie Iasi
Oncology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Oncomed S.R.L.
Oncology, Strada Porumbescu Ciprian Nr 59, 300239, Timisoara
University Hospital Bratislava
Klinika pneumologie, ftizeologie a funkcnej diagnostiky SZU a UNB, Ruzinovska 6, Ruzinov, Bratislava
Vychodoslovensky Onkologicky Ustav a.s.
Oddelenie klinickej onkolgie, Rastislavova 43, Juh, Kosice
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Del Mar
Oncology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
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 |
|---|---|---|---|---|---|
| Croatia | 2022-07-26 | 2022-08-19 | 2026-01-29 | ||
| France | 2022-04-07 | 2022-08-08 | 2026-01-29 | ||
| Germany | 2024-04-18 | 2024-08-21 | 2026-01-29 | ||
| Greece | 2022-02-26 | 2023-12-07 | 2026-01-29 | ||
| Italy | 2021-09-24 | 2021-09-30 | 2026-01-29 | ||
| Netherlands | 2021-11-05 | 2021-11-12 | 2026-01-29 | ||
| Romania | 2022-07-19 | 2022-10-24 | 2026-01-29 | ||
| Slovakia | 2022-10-14 | 2022-10-17 | 2026-01-29 | ||
| Spain | 2021-10-22 | 2021-12-17 | 2026-01-29 | ||
| Sweden | 2022-03-07 | 2022-04-11 | 2026-01-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 147 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PCL Redacted 2023-507494-18-00 | N/A |
| Protocol (for publication) | D1_Protocol 2023-507494-18-00 Redacted | 6 |
| Protocol (for publication) | D1_Protocol 2023-507494-18-00 Redacted GR | 6 |
| Protocol (for publication) | D4_Patient facing documents_PRO-Q Interviewer Administered | 1 |
| Protocol (for publication) | D4_Patient facing documents_PRO-Q Self Administered Booklet | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PRO-Q Self Administered Booklet | 3 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_de | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_es | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_fr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_gb | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_hr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_nl | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_ro | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_se | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-eq-5d-5l_sk | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_de | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_es | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_fr | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_gb | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_gr | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_hr | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_nl | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_ro | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_se | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-il46_sk | 1.1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_de | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_es | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_fr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_gb | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_hr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_nl | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_ro | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_se | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-bn20_sk | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_de | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_es | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_fr | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_gb | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_gr | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_hr | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_it | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_nl | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_ro | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_se | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-c30_sk | 2 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_de | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_es | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_fr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_gb | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_hr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_nl | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_ro | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_se | 1 |
| Protocol (for publication) | d4_patient-facing-documents_intadm-qlq-lc13_sk | 1 |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_de | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_es | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_fr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_gb | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_gr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_hr | 1 |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_it | 1 |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_nl | 1 |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_ro | 1 |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_se | 1 |
| Protocol (for publication) | d4_patient-facing-documents_selfad-lc13_sk | 1 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_de | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_es | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_fr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_gb | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_gr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_hr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_it | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_nl | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_ro | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_se | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-bn20_sk | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_de | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_es | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_fr | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_gb | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_gr | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_hr | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_it | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_nl | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_ro | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_se | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-c30_sk | 3.0 |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_de | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_es | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_fr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_gb | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_gr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_hr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_it | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_nl | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_ro | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_se | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-eq-5d-5l_sk | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_de | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_es | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_fr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_gb | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_gr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_hr | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_it | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_nl | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_ro | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_se | NA |
| Protocol (for publication) | d4_patient-facing-documents_selfadm-il46_sk | NA |
| Recruitment arrangements (for publication) | K_ Recruitment arrangement | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure form | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 3 |
| Recruitment arrangements (for publication) | K2_Document_additionnel | 1 |
| Subject information and informed consent form (for publication) | L1_Recruitment and Informed consent procedure form | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Appendix 1 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Appendix 2 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Appendix 3 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Appendix 4 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsies | 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 Consent Form | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS MO41552_Pregnant Partner_kind_ICF | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_MO41552 Main ICF | 3.2 |
| Subject information and informed consent form (for publication) | L1_SIS_MO41552_ICF niet-verplicht tumorbiopt | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS_MO41552_ICF Ziekte verergering | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS_MO41552_RBR ICF | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Xalkori | NA |
| Summary of Product Characteristics (SmPC) (for publication) | Xalkori-SmPC_oct20-22_single_doc_comparison | NA |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DE 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ES 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_GR 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IT 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_RO 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_SE 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_SK 2023-507494-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-507494-18-00 | 1.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | Germany | Acceptable 2024-02-16
|
2024-02-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-11 | Germany | Acceptable 2024-08-12
|
2024-08-12 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-11 | Germany | Acceptable 2024-08-12
|
2024-12-11 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-09 | Germany | Acceptable 2025-07-04
|
2025-07-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-05 | Acceptable | 2025-08-25 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-27 | Acceptable | 2026-01-20 |