Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
420
Countries
8
Sites
85
non-small cell lung cancer
To compare the treatment effect of Daraxonrasib versus docetaxel in the RAS (G12X-C) population.
Key facts
- Sponsor
- Revolution Medicines Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518154-16-00
- ClinicalTrials.gov
- NCT06881784
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Pharmacokinetic, Efficacy
To compare the treatment effect of Daraxonrasib versus docetaxel in the RAS (G12X-C) population.
Conditions and MedDRA coding
non-small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- At least 18 years of age and has provided informed consent.
- ECOG performance status 0 or 1.
- Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy
- Measurable disease per RECIST v1.1
- Adequate organ function (bone marrow, liver, kidney, coagulation)
- One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
- Documented RAS mutation status, defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)
- Able to take oral medications
- For the full list of inclusion criteria please refer to the protocol.
Exclusion criteria 6
- Prior therapy with any direct RAS-targeted therapy or docetaxel
- Untreated central nervous system (CNS) metastases
- Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function)
- Ongoing anticancer therapy
- Pregnant or breastfeeding
- For the full list of exclusion criteria please refer to the protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS is defined as time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 as assessed by Investigator. OS is defined as time from randomization until death from any cause.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10818590 · Product
- Active substance
- (12M-1S2S-N-63S4SZ-11-ETHYL-12-2-S-1-METHOXYETHYL-5-4-METHYLPIPERAZIN-1-YLPYRIDIN-3-YL-1010-DIMETHYL-57-DIOXO-616263646566-HEXAHYDRO-11H-8-OXA-242-THIAZOLA-153-INDOLA-613-PYRIDAZINACYCLOUNDECAPHANE-4-YL-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 120000 mg milligram(s)
- Max treatment duration
- 20 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10818589 · Product
- Active substance
- (12M-1S2S-N-63S4SZ-11-ETHYL-12-2-S-1-METHOXYETHYL-5-4-METHYLPIPERAZIN-1-YLPYRIDIN-3-YL-1010-DIMETHYL-57-DIOXO-616263646566-HEXAHYDRO-11H-8-OXA-242-THIAZOLA-153-INDOLA-613-PYRIDAZINACYCLOUNDECAPHANE-4-YL-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 120000 mg milligram(s)
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2025 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 20 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- labeling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Revolution Medicines Inc.
- Sponsor organisation
- Revolution Medicines Inc.
- Address
- 700 Saginaw Drive
- City
- Redwood City
- Postcode
- 94063-4752
- Country
- United States
Scientific contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Minoti Hiremath
Public contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Minoti Hiremath
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, E-data capture |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 2, Code 5 |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Primevigilance USA Inc. ORG-100047266
|
Raleigh, United States | Other, Code 8 |
| Aperio Clinical Outcomes LLC ORG-100046387
|
Durham, United States | Data management |
| Cytel Inc. ORG-100042560
|
Cambridge, United States | Other |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Cisys Inc. ORG-100046011
|
Raleigh, United States | Other |
Locations
8 EU/EEA countries · 85 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 22 | 6 |
| France | Ongoing, recruiting | 64 | 17 |
| Germany | Ongoing, recruiting | 48 | 11 |
| Ireland | Ongoing, recruiting | 15 | 7 |
| Italy | Ongoing, recruiting | 50 | 16 |
| Netherlands | Ongoing, recruiting | 29 | 6 |
| Poland | Ongoing, recruiting | 14 | 4 |
| Spain | Ongoing, recruiting | 54 | 18 |
| Rest of world
Puerto Rico, Hong Kong, Korea, Republic of, New Zealand, Singapore, Australia, Japan, United States, Switzerland, Taiwan, United Kingdom
|
— | 124 | — |
Investigational sites
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Universitair Ziekenhuis Antwerpen
Pneumology, Drie Eikenstraat 655, 2650, Edegem
Grand Hopital De Charleroi
Pneumology, Rue Du Campus Des Viviers 1, 6060, Charleroi
Algemeen Ziekenhuis Delta
Oncology, Deltalaan 1, 8800, Roeselare
UZ Leuven
Pulmonology, Herestraat 49, 3000, Leuven
Algemeen Ziekenhuis Groeninge
Pneumology, President Kennedylaan 4, 8500, Kortrijk
Assistance Publique Hopitaux De Paris
Thoracic oncology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Institut Curie
Thoracic oncology, 26 Rue D Ulm, 75005, Paris
Les Hopitaux Universitaires De Strasbourg
Pneumology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Lille
Thoracic oncology, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Hospices Civils De Lyon
Pneumology, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Nantes
Medical oncology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Institut Gustave Roussy
Thoracic oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Rennes
Pneumology, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Hospitalier Intercommunal Creteil
Pneumology, 40 Avenue De Verdun, 94010, Creteil Cedex
Centre Hospitalier Regional De Marseille
Thoracic oncology, 265 Chemin Des Bourrely, 13015, Marseille
Institut De Cancerologie De L Ouest
Medical Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Universitaire De Toulouse
Pneumology, 24 Chemin De Pouvourville, 31400, Toulouse
Centre Hospitalier Universitaire Grenoble Alpes
Pneumology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Regional Et Universitaire De Brest
Medical Oncology, Boulevard Tanguy Prigent, 29200, Brest
Institut Regional Du Cancer De Montpellier
Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Klinikum Esslingen GmbH
Klinik für Kardiologie, Angiologie und Pneumologie, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Pneumology, Lindenberger Weg 27, Buch, Berlin
Universitaetsmedizin Goettingen
Klinik für Haematologie and Medizinische Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Schleswig-Holstein AöR
Medizinische Klinik III -Pulmologie, Ratzeburger Allee 160, 23538, Luebeck
Muenchen Klinik gGmbH
Pneumologie und Pneumologische Onkologie, Englschalkinger Strasse 77, Bogenhausen, Munich
Asklepios Klinik Gauting GmbH
Oncology, Robert-Koch-Allee 2, 82131, Gauting
Thoraxklinik Heidelberg gGmbH
Thoracic Oncology, Roentgenstrasse 1, Rohrbach, Heidelberg
Justus-Liebig-Universitaet Giessen
Clinical Oncology and Palliative Care, Klinikstrasse 33, 35392, Giessen
Universitaetsklinikum Essen AöR
Westdeutsches Tumorzentrum, Innere Klinik, Hufelandstrasse 55, Holsterhausen, Essen
Technische Universitaet Dresden
Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Lungenfachklinik Immenhausen
Pneumologische Lehrklinik der Universitätsmedizin Göttingen, Robert-Koch-Str. 3, 34376, Immenhausen
St Vincent's University Hospital
Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Mater Private Hospital
Oncology, Eccles Street, D07 WKW8, Dublin 7
Cork University Hospital
Oncology, Wilton, T12 DC4A, Cork
Tallaght University Hospital
Oncology, Tallaght, D24 NR0A, Dublin 24
University Hospital Limerick
Oncology, Saint Nessan's Road, V94 F858, Limerick
University Hospital Galway
Oncology, Newcastle Road, H91 YR71, Galway
Beaumont Hospital
Oncology, Beaumont Road, Beaumont, Dublin 9
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology 1, Via Giacomo Venezian 1, 20133, Milan
Ospedale San Raffaele S.r.l.
Medical Oncology, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Parma
Medical Oncology, Viale Antonio Gramsci 14, 43126, Parma
ASST Grande Ospedale Metropolitano Niguarda
Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
I.F.O. Istituti Fisioterapici Ospitalieri
Medical Oncology 2, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliera Universitaria Integrata Verona
Oncology, Piazzale Aristide Stefani 1, 37126, Verona
Fondazione IRCCS San Gerardo Dei Tintori
Medical Oncology, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Medical Oncology, Regione Gonzole 10, 10043, Orbassano
Humanitas Mirasole S.p.A.
Medical Oncology and Hematology Unit, Via Alessandro Manzoni 56, 20089, Rozzano
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Medical Oncology Thoraco-Pulmonary, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Medical Oncology, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Onco-Hematology, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Pisana
Medical Oncology, Via Paradisa 2, 56124, Pisa
Istituto Europeo Di Oncologia S.r.l.
Thoracic Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Medical Oncology, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliera Di Perugia
Medical Oncology, Piazzale Giorgio Menghini 9, 06129, Perugia
Academisch Ziekenhuis Maastricht
Department of pulmonology, P Debyelaan 25, 6229 HX, Maastricht
Radboud universitair medisch centrum Stichting
Department of pulmonology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Groningen
Department of pulmonology, Hanzeplein 1, 9713 GZ, Groningen
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department of pulmonology, Plesmanlaan 121, 1066 CX, Amsterdam
Amsterdam UMC Stichting
Department of pulmonology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department of pulmonology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Med Polonia Sp. z o.o.
N/A, Obornicka 262, 60-693, Poznan
Uniwersyteckie Centrum Kliniczne
Klinika Onkologii i Radioterapii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Instytut Genetyki I Immunologii Genim Sp. z o.o.
N/A, Ul. Filaretow 27/2, 20-609, Lublin
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Complejo Hospitalario Universitario Insular Materno Infantil
Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario De Jaen
Oncology, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De Jerez De La Frontera
Oncology, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Hospital Universitario Regional De Malaga
Oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martín Lagos S/n, 28040, 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 |
|---|---|---|---|---|---|
| Belgium | 2025-09-17 | 2025-09-17 | |||
| France | 2025-08-29 | 2025-08-29 | |||
| Germany | 2025-08-27 | 2025-08-27 | |||
| Ireland | 2025-11-05 | 2025-11-06 | |||
| Italy | 2025-10-03 | 2025-10-29 | |||
| Netherlands | 2025-09-17 | 2025-09-17 | |||
| Poland | 2025-09-30 | 2025-09-30 | |||
| Spain | 2025-10-27 | 2025-11-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 93 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_2024-518154-16-00_red-san | 3.0 |
| Protocol (for publication) | D4_Patient facing document_Patient Facing Documentation_copyright statement_san | 1.0 |
| Recruitment arrangements (for publication) | K1_2024-518154-16_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BEL_san | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 2.0 |
| Recruitment arrangements (for publication) | K1_RMC-6236-301_Recruitment and Informed consent procedure_San | 1 |
| Recruitment arrangements (for publication) | K1_RMC-6236-301_Recruitment arrangements-NL-san | V2.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment arrangements placeholder | 1 |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Banner Ads_Placeholder | N/A |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Digital Waiting Room Ad_Placeholder | V01FRAfr |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Dr to Patient Letter_Placeholder | V01FRAfr01 |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Patient Advocacy Group Letter_Placeholder | V01FRAfr01 |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Patient Brochure_Placeholder | V01FRAfr |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Patient Study Guide_Placeholder | V02FRAfr |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Physician Referral Letter_Placeholder | V01FRAfr01 |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Social Media Clinical Trial Posts_Placeholder | V01FRAfr |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Study Information Slides_Placeholder | 01Globalen |
| Recruitment arrangements (for publication) | K2_2024-518154-16_Recruitment material_Talking Points Guide_Placeholder | 01Globalen |
| Recruitment arrangements (for publication) | K2_Patient facing document_Placeholder_v1-0_27Feb2025 | 1 |
| Recruitment arrangements (for publication) | K2_Patient_Brochure | V01DEUde |
| Recruitment arrangements (for publication) | K2_RecruitMat_Banner Ads | V01.DEUde |
| Recruitment arrangements (for publication) | K2_RecruitMat_Digital Waiting Room Ad | V01.DEUde |
| Recruitment arrangements (for publication) | K2_RecruitMat_Dr-to-Patient Letter | V01DEUde01 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Patient Advocacy Group Letter | V01DEUde01 |
| Recruitment arrangements (for publication) | K2_RecruitMat_Social Media_Clinical Trial Posts | V01DEUde |
| Recruitment arrangements (for publication) | K2_Recruitment material_Banner Ads | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Waiting Room Ad | V01ITA(it) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr-to-Patient Letter | V01ITA(it) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Advocacy Group Letter | V01ITA(it) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure | V01ITA(it) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media and Clinical Trial Posts | V01ITA(it) |
| Recruitment arrangements (for publication) | K2_Recruitment materials placeholder | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials placeholder_san | 2 |
| Recruitment arrangements (for publication) | K2_RMC-6236-301_Banner Ads | N/A |
| Recruitment arrangements (for publication) | K2_RMC-6236-301_Digital Waiting Room Ad | V01NLD(nl) |
| Recruitment arrangements (for publication) | K2_RMC-6236-301_Dr-to-Patient Letter_San | V01NLD02 |
| Recruitment arrangements (for publication) | K2_RMC-6236-301_Patient Advocacy Group Letter_San | V01NLD(nl) |
| Recruitment arrangements (for publication) | K2_RMC-6236-301_Patient Brochure_San | V01NLD(nl) |
| Recruitment arrangements (for publication) | K2_RMC-6236-301_Physician Referral Letter | V02 |
| Recruitment arrangements (for publication) | K2_RMC-6236-301_Social Media and Clinical Trial Posts_San | V01NLD(nl) |
| Recruitment arrangements (for publication) | Patient Recruitment_Placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_BfS information for Germany | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF Redacted | 3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_Main no BfS ICF_red-san | 3.0DEU1.0 |
| Subject information and informed consent form (for publication) | L1_Main with BfS ICF_red-san | 3.0DEU1.0 |
| Subject information and informed consent form (for publication) | L1_Pre-screening ICF | V1-0DEUde2 |
| Subject information and informed consent form (for publication) | L1_Preg_ICF | 1.0DEU1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-6236-301_Main ICF_Ireland_redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_RMC-6236-301_Main ICF_Red-san | V3.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-6236-301_Pre-screening ICF_Red-san | V1.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-6236-301_Pregnancy ICF_Red-san | V1.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FSR_Red-San | 1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_EN_red | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_FR_red | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_NL_red | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Privacy_Red-San | 1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Red | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Red_San_CL | 3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Red-San_CL | 3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening ICF_EN_red | 1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening ICF_FR_red | 1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening ICF_NL_red | 1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pre-screening_Red-San | 1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Red_San | 1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_EN_san | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_FR_san | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_NL_san | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Red_San_CL | 1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Sponsorstatement_BEL_red | 1.0 |
| Subject information and informed consent form (for publication) | L2_2024-518154-16_ICF_Main ICF_Red-san | V3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L2_2024-518154-16_ICF_PP ICF_Red-san | V1-0FRA1-0 |
| Subject information and informed consent form (for publication) | L2_2024-518154-16_ICF_Pre-screening ICF_Red-san | V1-0FRA1-0 |
| Subject information and informed consent form (for publication) | L2_2024-518154-16_Patient ID Card | V02FRAfr01 |
| Subject information and informed consent form (for publication) | L2_ICF_Pregnant Partner_red | V1.0POL2.0 |
| Subject information and informed consent form (for publication) | L2_ICF_Prescreening ICF_red | V1.0POL1.0 |
| Subject information and informed consent form (for publication) | L2_Ireland GP Letter Template V01 7Feb2025 | 1 |
| Subject information and informed consent form (for publication) | L2_Pre-screening ICF Redacted | 1.0ESP2.0 |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner ICF_Redacted | 1.0ESP3.0 |
| Subject information and informed consent form (for publication) | L2_RMC-6236-301 Pregnant Partner ICF_Ireland_V1_05Feb2025_Final_clean | 1 |
| Subject information and informed consent form (for publication) | L2_RMC-6236-301_Optional and Future Research ICF_Ireland_V1_08May2025_Final | 1.1 |
| Subject information and informed consent form (for publication) | L2_RMC-6236-301_Pre-screening ICF_Ireland_V1_05Feb2025_Final_clean _redacted | 1.2 |
| Subject information and informed consent form (for publication) | Obsolete_L1_SIS and ICF_Main_Red_San | 3.0ITA1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Representative SmPC_Docetaxel | N/A |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_BE_DE_2024-518154-16-00_red-san | 3.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_BE_FR_2024-518154-16-00_red-san | 3.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_BE_NL_2024-518154-16-00_red-san | 3.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_ENG_2024-518154-16-00_red-san | 3.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_ES_2024-518154-16-00_red-san | 3.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_FR_2024-518154-16-00_red-san | 3.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_IT_2024-518154-16-00_red-san | 3.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_NL_2024-518154-16-00_red-san | 3.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_PL_2024-518154-16-00_red-san | 3.1 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-10 | Germany | Acceptable 2025-06-30
|
2025-07-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-09 | Acceptable | 2025-08-12 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-09 | Acceptable | 2025-08-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-09 | Germany | Acceptable | 2025-08-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-09 | Acceptable | 2025-07-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-09 | Acceptable | 2025-08-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-09 | Acceptable | 2025-08-07 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-09 | Acceptable | 2025-08-19 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-09 | Acceptable | 2025-08-06 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-09-30 | Germany | Acceptable 2025-12-19
|
2025-12-22 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-21 | Acceptable 2025-12-19
|
2026-01-21 |