Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
100
Countries
9
Sites
42
Lung Cancer
To evaluate the ORR as assessed by RECIST v1.1 criteria of zoldonrasib monotherapy in patients with RAS G12D-mutant NSCLC who have been previously treated with systemic therapy
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
- 2 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Revolution Medicines Inc
External identifiers
- EU CT number
- 2025-521681-10-00
- ClinicalTrials.gov
- NCT06162221
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the ORR as assessed by RECIST v1.1 criteria of zoldonrasib monotherapy in patients with RAS G12D-mutant NSCLC who have been previously treated with systemic therapy
Secondary objectives 1
- To evaluate other measures of efficacy ofzoldonrasib monotherapy in patients with RG12D-mutant NSCLC who have been previously treated with systemic therapy. To evaluate the safety and tolerability of zoldonrasib in patients with RAS G12D-mutant. To characterize the PK of zoldonrasib.
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 |
|---|---|---|
| 2023-509571-16-00 | 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. |
| 2025-521147-21-00 | A Phase 1b/2 Open-Label, Multicenter Study of RMC-9805 with or without RMC-6236, in Combination with Other Anticancer Agents, in Patients with RAS G12D-Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol C | Revolution Medicines Inc. |
| 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. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients that are at least 18 years of age
- Patients that have NSCLC with RAS-G12D mutation
- Patients that have had cancer treatment before or are not able to tolerate regular treatments.
- Patients that have at least 1 measurable tumor (lesion).
- Patients that have adequate organ function (bone marrow, liver, kidney) and blood clotting.
Exclusion criteria 6
- 1. Patients that have primary brain and spinal cord tumor.
- 2. Patients thathave gastrointestinal problems that may affect absorption of RMC-9805
- 3. Patients thathad any major surgery in the last 4 weeks.
- 4. Patients that have any other medical condition that may interfere with the study medicine.
- 5. Patient that have a history of severe allergic reactions to the study medicine.
- 6. Patients that have previously taken targeted therapy for KRAS mutation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Confirmed ORR per RECIST v1.1 as assessed by BICR
Secondary endpoints 8
- •PFS
- • OS
- • DOR
- • TTR
- • DCR
- • PFS rate at 6 months and 12 months and OS rate at 12 months
- • Incidence of TEAEs, SAEs, and changes from baseline in clinical laboratory values and vital signs.
- • Zoldonrasib blood concentration over time
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
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
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
- Melanie Caruno
Public contact point
- Organisation
- Revolution Medicines Inc.
- Contact name
- Melanie Caruno
Third parties 19
| Organisation | City, country | Duties |
|---|---|---|
| Myonex LLC ORG-100047430
|
Horsham, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Laboratory analysis |
| Tempus AI Inc. ORG-100044006
|
Chicago, United States | Laboratory analysis |
| Atreo Inc. ORG-100045217
|
San Francisco, United States | Interactive response technologies (IRT) |
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | Code 12, Other, Code 5 |
| Propharma Group LLC ORG-100048652
|
Raleigh, United States | Code 9 |
| PPD Denmark Filial Af PPD Scandinavia AB Sverige ORG-100006387
|
Copenhagen S, Denmark | Code 12, Other, Code 5 |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Primevigilance Limited ORG-100027742
|
Guildford, United Kingdom | Code 8 |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Aperio Clinical Outcomes LLC ORG-100046387
|
Durham, United States | Data management |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Discovery Life Sciences LLC ORG-100046461
|
Huntsville, United States | Laboratory analysis |
| Sherpa Clinical Packaging LLC ORG-100042876
|
San Diego, United States | Other |
| Edetek Inc. ORG-100045957
|
Princeton, United States | Other |
Locations
9 EU/EEA countries · 42 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 5 | 2 |
| Czechia | Authorised, recruitment pending | 5 | 1 |
| Denmark | Ongoing, recruitment ended | 8 | 2 |
| France | Ongoing, recruitment ended | 17 | 12 |
| Germany | Authorised, recruitment pending | 8 | 4 |
| Greece | Ongoing, recruitment ended | 5 | 2 |
| Italy | Ongoing, recruitment ended | 9 | 4 |
| Netherlands | Ongoing, recruitment ended | 8 | 3 |
| Spain | Ongoing, recruitment ended | 19 | 12 |
| Rest of world
Korea, Republic of, Taiwan, Australia, Hong Kong, Malaysia, Singapore, United States
|
— | 16 | — |
Investigational sites
Noe LGA Gesundheit Region Mitte GmbH
Klinische Abteilung für Innere Medizin 1, Dunant-Platz 1, 3100, St. Poelten
Stadt Wien Wiener Gesundheitsverbund
c/o Klinik Floridsdorf Abteilung für Innere Medizin und Lungenforschung, Bruenner Strasse 68, Floridsdorf, Vienna
Nemocnice AGEL Novy Jicin a.s.
n/a, Purkynova 2138/16, 741 01, Novy Jicin
Rigshospitalet
Department of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Department of Oncology, J. B. Winsloews Vej 4, 5000, Odense C
Centre Francois Baclesse
N/A, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital Foch
N/A, 40 Rue Worth, 92150, Suresnes
Centr Georges Francois Leclerc
N/A, 1 Rue Professeur Marion, 21000, Dijon
Institut Curie
N/A, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Nantes
N/A, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Oncopole Claudius Regaud
N/A, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Assistance Publique Hopitaux De Paris
N/A, 4 Rue De La Chine, 75020, Paris
Institut Bergonie
N/A, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Universitaire De Lille
N/A, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hopital Ambroise Pare
Department of Respiratory Diseases and Thoracic-Oncology, 9 Avenue Charles De Gaulle, 92100, Boulogne Billancourt
Hospices Civils De Lyon
N/A, 59 Boulevard Pinel, 69500, Bron
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Onkologie, Hämatologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Goethe University Frankfurt
Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
University Hospital Cologne AöR
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
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department: SSD Oncologia polmonare-A.O.U. San Luigi Gonzaga - Orbassano, Regione Gonzole 10, 10043, Orbassano
ASST Grande Ospedale Metropolitano Niguarda
Department: SC Oncologia Falck, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Unita Sanitaria Locale Della Romagna
Unità Clinica Fase 1 – UO Oncologia di Ravenna, Viale Vincenzo Randi 5, 48121, Ravenna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità Operativa Complessa Fase 1, Largo Francesco Vito 1, 00168, Rome
Universitair Medisch Centrum Utrecht
Medical Oncology, Heidelberglaan 100, 3584 CX, Utrecht
Leids Universitair Medisch Centrum (LUMC)
Department of Pulmonary Diseases, Albinusdreef 2, 2333 ZA, Leiden
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Clinical Research Unit, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario 12 De Octubre
Oncologia, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Oncologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Oncologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
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
Hospital Universitario Fundacion Jimenez Diaz
Oncologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinico San Carlos
Oncologia, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Y Politecnico La Fe
Oncologia, Avenida Fernando Abril Martorell 106, 46026, Valencia
Fundacion Instituto Valenciano De Oncologia
Oncologia, Calle Professor Beltran Baguena 8, 46009, Valencia
Clinica Universidad De Navarra
Oncologia, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Ramon Y Cajal
Oncologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Virgen Del Rocio S.L.
Oncologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Denmark | 2025-12-05 | 2026-01-09 | 2026-01-09 | ||
| France | 2025-10-31 | 2025-11-13 | 2026-02-24 | ||
| Greece | 2025-10-30 | 2025-12-03 | 2025-12-03 | ||
| Italy | 2025-12-04 | 2025-12-16 | 2026-01-23 | ||
| Netherlands | 2025-11-05 | 2025-12-19 | 2026-02-05 | ||
| Spain | 2025-10-02 | 2025-10-09 | 2026-01-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 81 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_2025-521681-10_GRK_EL_Public | 6.1 |
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol_2025-521681-10_Public | 6.1 |
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol_2025-521681-10_GRK_LE_Public | 1.1 |
| Protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol_2025-521681-10_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_AUT_AT_Public | 2.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_CZE_CZ_Public | 2.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_FRA_FR_Public | 2.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_GER_DE_Public | 2.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_GRC_EL_Public | 2.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_ITA_IT_Public | 2.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_NLD_BE_Public | 2.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_Public | 2.0 |
| Protocol (for publication) | D4_RevMed_RMC-LUNG-101D_ Patient Diary_SPA_ES_Public | 2.0 |
| Protocol (for publication) | RevMed_RMC-LUNG-101_Core Protocol_Signature Page_Public | 6.0 |
| Protocol (for publication) | RevMed_RMC-LUNG-101_Subprotocol D_Signature Page_ Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101 SubProtocol D_Recruitment-Arrangements_GRC_Public | N/A |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101_ SubProtocolD_Recruitment-Arrangements_AT_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101_Recruitment_Informed-Consent-Procedure_CZ_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101_Subprotocol-D_Recruitment-and-Informed-Consent-Procedure_DE | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101-D_Recruitment-arrangements_DNK_English | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101D_Recruitment-Arrangements_ES | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101D_Recruitment-Arrangements_FR_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101D_Recruitment-arrangements_NL_Public | n/a |
| Recruitment arrangements (for publication) | K1_RMC-LUNG-101D_Recruitment-Informed-Consent-Procedure_IT_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_RMC-LUNG-101D_GP-letter_IT_ITA_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_RMC-LUNG-101D_Patient_Card_FR_French_Public | 1.0.0 |
| Recruitment arrangements (for publication) | K2_RMC-LUNG-101D_Patient-Card_IT_Italian_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L1_ RMC-LUNG-101_Pregnant Partner _ICF_CZ_CS_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ RMC-LUNG-101_SubD_GDPR_ICF_CZ_CS_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ RMC-LUNG-101_SubD_Main_ICF_CZ_CS_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ RMC-LUNG-101_SubD_Pre-Screen_ICF_CZ_CS_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC_LUNG-101-D_Addendum-to-Main-consent-form_DNK_Danish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101 Subprotocol-D_Future Research ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_D_Main_ICF_AT-German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_D_Pre-screening ICF_AT-German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_D_Pregnancy_ICF_AT-German_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Pregnant Partner ICF_ES_Spanish_Public | 4.0 |
| 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_SubProtocol_D_Main-ICF_GRC_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_D_Main-ICF_GRC_Greek_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_D_Pre-Screening-ICF_GRC_English_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_D_Pre-Screening-ICF_GRC_Greek_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_D_Pregnancy-Follow-up-ICF_GRC_English_Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_SubProtocol_D_Pregnancy-Follow-up-ICF_GRC_Greek_Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Subprotocol-D_Main ICF_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Subprotocol-D_Pre-Screening ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101_Subprotocol-D_Pregnancy ICF_DE_German_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-D_ Main-ICF_DNK_Danish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-D_Main-Adult-ICF_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC-lung-101-D_PP-ICF_DNK_Danish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-D_Pre-screening-ICF_DNK_Danish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-D_Pre-Screening-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-D_Pregnant-Partner-ICF_IT_Italian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101-D_Privacy-Addendum-ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101A_Scout ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_Main ICF_ES_Spanish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_Main-ICF_FR_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_Pre-screening ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_Pre-screening ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_Pregnancy-ICF_FR_French_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_SIS-and-ICF_Certificates-of-Translation_NL_English_Public | n/a |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_SIS-and-ICF-adults_NL_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_SIS-and-ICF-pre-screening_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-LUNG-101D_SIS-and-ICF-pregnant-partner_NL_Dutch_Public | 4.0 |
| Subject information and informed consent form (for publication) | L2_RMC-LUNG-101_Site-Patient-advocacy_Contact-List-for-ICF_AT | N/A |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521681-10_AUT_AT_Public | 6.1 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521681-10_CZE_CZ_Public | 6.1 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521681-10_FRA_FR_Public | 6.1 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521681-10_ITA_IT_Public | 6.1 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521681-10_NLD_NL_Public | 6.1 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol Synopsis_2025-521681-10_Public | 6.1 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101_Core Protocol synopsis_2025-521681-10_SPA_ES_Public | 6.1 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_Protocol Lay Synopsis_2025-521681-10_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol Lay Synopsis_2025-521681-10_AUT-AT_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol Lay Synopsis_2025-521681-10_CZE_CZ_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol Lay Synopsis_2025-521681-10_FRA_FR_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol Lay Synopsis_2025-521681-10_GRK_LE_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol Lay Synopsis_2025-521681-10_ITA_IT_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol Lay Synopsis_2025-521681-10_NLD_NL_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol Lay Synopsis_2025-521681-10_SPA_ES_Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-LUNG-101D_SubProtocol Synopsis_2025-521681-10_ NLD_DU_Public | 6.1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-28 | Spain | Acceptable 2025-09-22
|
2025-09-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-29 | Acceptable | 2025-11-06 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-11 | Acceptable | 2025-12-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-12 | Acceptable | 2026-02-02 |