Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
216
Countries
9
Sites
49
Lung Cancer
To evaluate the safety and tolerability of RMC-9805 with or without RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12D-mutated solid tumors. To determine the RP2DS of RMC-9805 with or without RMC-6236 in combination with pembrolizumab, with or without chemothera…
Key facts
- Sponsor
- Revolution Medicines Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 8 Oct 2025 → ongoing
- Decision date (initial)
- 2025-10-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Revolution Medicines Inc
External identifiers
- EU CT number
- 2025-521147-21-00
- ClinicalTrials.gov
- NCT06162221
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the safety and tolerability of RMC-9805 with or without RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12D-mutated solid tumors.
To determine the RP2DS of RMC-9805 with or without RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12D-mutated NSCLC.
Secondary objectives 1
- To characterize the PK of RMC-9805 with or without RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12D-mutated NSCLC. To evaluate the antitumor activity of RMC-9805 with or without RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS G12D-mutated NSCLC.
Conditions and MedDRA coding
Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509572-42-00 | A Phase 1b/2 Open-Label, Multicenter Study of RMC-6236 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with RAS‑Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol B | Revolution Medicines Inc. |
| 2023-509571-16-00 | A Phase 1b/2 Open-Label, Multicenter Study of RMC-6291 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with KRASG12C-Mutated Solid Tumors – Subprotocol A | Revolution Medicines Inc. |
| 2025-521681-10-00 | A Phase 2, Open-Label, Multicenter Study of Zoldonrasib(RMC-9805) in Previously Treated Patients with RAS G12DMutant Non-Small Cell Lung Cancer (NSCLC) – Subprotocol D | Revolution Medicines Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Patients that are at least 18 years of age
- 2. Patients that have NSCLC with RAS-G12D mutation.
- 3. Patients that have had cancer treatment before or are not able to tolerate regular treatments.
- 4. Patients that have at least 1 measurable tumor (lesion).
- 5. Patients that have adequate organ function (bone marrow, liver, kidney) and blood clotting.
Exclusion criteria 5
- 1. Patients that have primary brain and spinal cord tumor.
- 2. Patients that have gastrointestinal problems that may affect absorption of the study drug medicine
- 3. Patients that had any major surgery in the last 4 weeks.
- 4. Patients that have any other medical condition that may interfere with the study medicine.
- 5. Patients that have previously taken targeted therapy for KRAS mutation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 1. Incidence of DLTs; Part 1 and Part 2 (Cohort C3 safety lead-in only).
- 2. Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in vital signs, laboratory test values, and ECGs.
Secondary endpoints 2
- 1. Concentrations of RMC-9805 and RMC-6236 (if applicable) in blood over time.
- 2. ORR and DOR as per RECIST v1.1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 35.71 mg milligram(s)
- Max total dose
- 750 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09655MIG · Substance
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 23.8 mg/m2 milligram(s)/sq. meter
- Max total dose
- 500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 3.57 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD12324715 · Product
- Active substance
- (2S-2-CYCLOPENTYL-2-5S-2-2R3R-3-CYCLOPROPYL-1-METHYLAZIRIDINE-2-CARBONYL-27-DIAZASPIRO44NONAN-7-YL-N-6S8S14S-21-5-4-CYCLOPROPYLPIPERAZIN-1-YL-2-1S-1-METHOXYETHYLPYRIDIN-3-YL-1818-DIMETHYL-915-DIOXO-22-222-TRIFLUOROETHYL-516-DIOXA-2102228-TETRAZAPENTACYCLO18521261101402327NONACOSA-12620232724-TETRAEN-8-YLACETAMIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9.52 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
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
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
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
- Marie Keegan
Public contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Marie Keegan
Third parties 19
| Organisation | City, country | Duties |
|---|---|---|
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | Code 12, Other, Code 5 |
| Sherpa Clinical Packaging LLC ORG-100042876
|
San Diego, United States | Other |
| Discovery Life Sciences LLC ORG-100046461
|
Huntsville, United States | Laboratory analysis |
| Aperio Clinical Outcomes LLC ORG-100046387
|
Durham, United States | Data management |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Other |
| Atreo Inc. ORG-100045217
|
San Francisco, United States | Interactive response technologies (IRT) |
| Tempus AI Inc. ORG-100044006
|
Chicago, United States | Laboratory analysis |
| Myonex LLC ORG-100047430
|
Horsham, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Primevigilance Limited ORG-100027742
|
Guildford, United Kingdom | Code 8 |
| PPD Denmark Filial Af PPD Scandinavia AB Sverige ORG-100006387
|
Copenhagen S, Denmark | On site monitoring |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Other |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Laboratory analysis |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Propharma Group LLC ORG-100048652
|
Raleigh, United States | Code 9 |
| Edetek Inc. ORG-100045957
|
Princeton, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
Locations
9 EU/EEA countries · 49 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruiting | 6 | 2 |
| Czechia | Authorised, recruiting | 3 | 1 |
| Denmark | Authorised, recruiting | 6 | 2 |
| France | Ongoing, recruiting | 38 | 14 |
| Germany | Ongoing, recruiting | 12 | 5 |
| Greece | Authorised, recruiting | 16 | 4 |
| Italy | Ongoing, recruiting | 16 | 5 |
| Netherlands | Ongoing, recruiting | 9 | 3 |
| Spain | Ongoing, recruiting | 24 | 13 |
| Rest of world
Korea, Republic of, United States, Hong Kong, Australia, Taiwan
|
— | 86 | — |
Investigational sites
Noe LGA Gesundheit Region Mitte GmbH
Klinische Abteilung für Innere Medizin 1, Dunant-Platz 1, 3100, St. Poelten
Stadt Wien Wiener Gesundheitsverbund
Abteilung für Innere Medizin und Lungenforschung, Bruenner Strasse 68, Floridsdorf, Vienna
Nemocnice AGEL Novy Jicin a.s.
Oddeleni onkologie a radioterapie, Purkynova 2138/16, 741 01, Novy Jicin
Odense University Hospital
Department of Oncology, J. B. Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Assistance Publique Hopitaux De Paris
Oncology Thoracic Unit Pneumology Service, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Lille
Pulmonology and thoracic Oncology Department, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Oncopole Claudius Regaud
Medical Oncology Department, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nantes
Oncology Medical Department, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Hopital Ambroise Pare
Department of Respiratory Diseases and Thoracic-Oncology, 9 Avenue Charles De Gaulle, 92100, Boulogne Billancourt
Institut Curie
Medical Oncology Department, 26 Rue D Ulm, 75005, Paris
Assistance Publique Hopitaux De Paris
Chest Department, 4 Rue De La Chine, 75020, Paris
Institut Gustave Roussy
DITEP (Medical Oncology in Early Drug Development Department), 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
Pulmonology Department, 28 Avenue Du Doyen Jean Lepine, 69500, Bron
Centr Georges Francois Leclerc
Medical Oncology Department, 1 Rue Professeur Marion, 21000, Dijon
Institut De Cancerologie De L Ouest
Oncology Department, 15 Rue Andre Boquel, 49100, Angers
Institut Bergonie
Medical Oncology Department, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Hospital Foch
Medical Oncology Department, 40 Rue Worth, 92150, Suresnes
Centre Francois Baclesse
Department of pneumology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Goethe University Frankfurt
Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Onkologie, Hämatologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Thoraxklinik Heidelberg gGmbH
n/a, Roentgenstrasse 1, Rohrbach, Heidelberg
University Hospital Cologne AöR
Uniklinik Köln Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Henry Dunant Hospital Center
D’ Oncology clinic & Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
Thoracic General Hospital Of Athens I Sotiria
Oncology Unit, 3'd Department of Ιnternal Medicine and Laboratory, Messogion Avenue 152, 115 27, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Pulmonary Department Aristotle University of Thessaloniki, Exochi, 570 10, Thessaloniki
Athens Medical Center S.A.
4th Department of Medical Oncology, Pylea, Asklipiou 10, Thessaloniki
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità Operativa Complessa Fase 1, Largo Francesco Vito 1, 00168, Rome
Azienda Unita Sanitaria Locale Della Romagna
Unità Clinica Fase 1 – UO Oncologia di Ravenna, Viale Vincenzo Randi 5, 48121, Ravenna
ASST Grande Ospedale Metropolitano Niguarda
SC Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
SSD Oncologia polmonare-A.O.U. San Luigi Gonzaga - Orbassano, Regione Gonzole 10, 10043, Orbassano
Istituto Europeo Di Oncologia S.r.l.
Divisione di sviluppo di nuovi farmaci per terapie innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Leids Universitair Medisch Centrum (LUMC)
Department of Pulmonary Diseases, Albinusdreef 2, 2333 ZA, Leiden
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Clinical Research Unit, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Quironsalud Madrid
NEXT Oncology Madrid Phase I Unit, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Clinico San Carlos
Oncologia, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Fundacion Instituto Valenciano De Oncologia
Oncologia, Calle Professor Beltran Baguena 8, 46009, Valencia
Hospital Universitari Vall D Hebron
Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncologia, Avenida De Cordoba Sn, 28041, Madrid
University Hospital Virgen Del Rocio S.L.
Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Y Politecnico La Fe
Oncologia, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Regional De Malaga
Oncologia Medica, Avenida De Carlos De Haya S/N, 29010, Malaga
Complexo Hospitalario Universitario A Coruna
Oncologia Medica, Lugar Jubias De Arriba 84, 15006, A Coruna
Clinica Universidad De Navarra
Oncologia, Pio XII Etorbidea 36, 31008, Pamplona
Clinica Universidad De Navarra
Oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Ramon Y Cajal
Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, 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 | 2026-02-13 | ||||
| Czechia | 2026-03-31 | ||||
| Denmark | 2026-03-10 | ||||
| France | 2025-10-31 | 2025-12-30 | |||
| Germany | 2025-11-06 | 2025-12-29 | |||
| Greece | 2026-01-29 | ||||
| Italy | 2026-01-29 | 2026-02-24 | |||
| Netherlands | 2025-11-05 | 2026-02-10 | |||
| Spain | 2025-10-08 | 2025-12-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 103 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol_2025-521147-21_GRK_EL_Public | Am5.2 v6.2 |
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol_2025-521147-21_Public | AM5,v2.6.2 |
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101C_SubProtocol_2025-521147-21_GRK_LE_Public | Am1.2 v2.2 |
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101C_SubProtocol_2025-521147-21_Public | AM1_2.2.2 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 BID and RMC-6236 QD_CZE_CZ_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 BID and RMC-6236 QD_FRA_FR_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 BID and RMC-6236 QD_GER_DE_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 BID and RMC-6236 QD_GRC_EL_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 BID and RMC-6236 QD_ITA_IT_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 BID and RMC-6236 QD_NLD_NL_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 BID and RMC-6236 QD_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 BID and RMC-6236 QD_SPA_ES_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 QD and RMC-6236 QD_CZE_CZ_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 QD and RMC-6236 QD_FRA_FR_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 QD and RMC-6236 QD_GER_DE_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 QD and RMC-6236 QD_GRC_EL_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 QD and RMC-6236 QD_ITA_IT_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 QD and RMC-6236 QD_NLD_NL_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 QD and RMC-6236 QD_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805 QD and RMC-6236 QD_SPA_ES_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805_CZE_CZ_Public | 4.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805_FRA_FR_Public | 3.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805_GER_DE_Public | 3.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805_GRC_EL_Public | 3.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805_ITA_IT_Public | 3.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805_Public | 3.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_ Patient Diary RMC-9805_SPA_ES_Public | 3.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_Patient Diary RMC-9805 BID and RMC-6236 QD_AUT_DU_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_Patient Diary RMC-9805 QD and RMC-6236 QD_AUT_DU_Public | 5.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101C_Patient Diary RMC-9805_AUT_DU_Public | 3.0 |
| Protocol (for publication) | RevMed_RMC-LUNG-101_Core Protocol_Signature Page_Public | n/a |
| Protocol (for publication) | RevMed_RMC-LUNG-101C_SubProtocol_Signature Page_Public | n/a |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101_Recruitment_Informed-Consent-Procedure_CZ_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101_SubC_Recruitment-and-Informed-Consent-Procedure_DE_English | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101_SubProtocol C_Recruitment-Arrangements_GRC_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101_Subprotocol-C_Recruitment-Arrangements_AT_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101-C_Recruitment-arrangements_DNK_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101C_Recruitment-Arrangements_ES_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101C_Recruitment-Arrangements_FR_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101C_Recruitment-arrangements_NL_Public | N/A |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101C_Recruitment-Informed-Consent-Procedure_IT_English | 1.0 |
| Recruitment arrangements (for publication) | K2_RMC-LUNG-101C_ Patient-Card_IT_Italian_Public | 2.0.0 |
| Recruitment arrangements (for publication) | K2_RMC-LUNG-101C_GP-letter_IT_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_RMC-LUNG-101C_Patient-Card_IT_Italian_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_ RMC-LUNG-101_SubC_GDPR_ICF_CZ_CS_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ RMC-LUNG-101_SubC_Main_ICF_CZ_CS_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ RMC-LUNG-101_SubC_Pre-Screening _ICF_CZ_CS_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ RMC-LUNG-101_SubC_Pregnant Partner_ICF_CZ_CS_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC_LUNG-101-C_Addendum-to-Main-consent-form_DNK_Danish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Pregnancy_ICF_AT-German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Pregnant Partner ICF_ES_Spanish_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Scout ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Scout ICF_ES_Spanish_Public | 0.2 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubC_Future-Research-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubC_Main-ICF_AUT_aut_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubC_Main-ICF-Part1_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubC_Main-ICF-Part2_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubC_PP-ICF_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubC_Pre-screening-ICF_AT-German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubC_Pre-Screening-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubC_Pregnant Participant ICF_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_C_Main-ICF_GRC_English_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_C_Main-ICF_GRC_Greek_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_C_Pre-Screening-ICF_GRC_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_C_Pre-Screening-ICF_GRC_Greek_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_C_Pregnancy-Follow-up-ICF_GRC_English_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_C_Pregnancy-Follow-up-ICF_GRC_Greek_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_ Main-ICF_DNK_Danish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_Main_ICF_FR_French_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_Main-Adult-ICF_IT_Italian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_PP-ICF_DNK_Danish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_Pre_screening_ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_Pre-screening-ICF_DNK_Danish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_Pre-Screening-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_Pregnant-Partner-ICF_IT_Italian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-C_Privacy-Addendum-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-D_Optional-Biopsy-ICF_DNK_Danish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101C_Main ICF_ES_Spanish_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101C_Pre-screening ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101C_Pregnant Partner_ICF_FR_French_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101C_SIS-and-ICF-adults_NL_Dutch_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101C_SIS-and-ICF-pre-screening_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101C_SIS-and-ICF-pregnant-partner_NL_Dutch_Public | 5.0 |
| Subject information and informed consent form (for publication) | L2_RMC-LUNG-101_SubC_Site-Patient-advocacy_Contact-List-for-ICF_AT | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101C_Representative SmPC_Carboplatin_ENG | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101C_Representative SmPC_Cisplatin_ENG | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101C_Representative SmPC_Pembrolizumab_ENG | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-LUNG-101C_Representative SmPC_Pemetrexed_ENG | n/a |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521147-21_AUT_AT_Public | AM5,v2.6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521147-21_CZE_CZ_Public | AM5,v2.6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521147-21_FRA_FR_Public | AM5,v2.6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521147-21_ITA_IT_Public | AM5,v2.6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521147-21_NLD_NL_Public | AM5,v2.6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol Synopsis_2025-521147-21_Public | AM5,v2.6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521147-21_SPA_ES_Public | AM5,v2.6.2 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101C_Protocol Lay Synopsis_2025-521147-21_AUT_AT_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101C_Protocol Lay Synopsis_2025-521147-21_CZE_CZ_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101C_Protocol Lay Synopsis_2025-521147-21_FRA_FR_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101C_Protocol Lay Synopsis_2025-521147-21_GRK_LE_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101C_Protocol Lay Synopsis_2025-521147-21_ITA_IT_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101C_Protocol Lay Synopsis_2025-521147-21_NLD_DU_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101C_Protocol Lay Synopsis_2025-521147-21_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101C_Protocol Lay Synopsis_2025-521147-21_SPA_ES_Public | 2.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-20 | Spain | Acceptable 2025-10-03
|
2025-10-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-23 | Acceptable | 2025-11-06 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-24 | Acceptable | 2025-12-10 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-30 | Spain | Acceptable | 2025-11-06 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-27 | Acceptable | 2026-01-14 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-25 | Spain | Acceptable 2026-05-26
|
2026-05-28 |