Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
345
Countries
7
Sites
53
Solid Tumors
• To evaluate the safety and tolerability of RAS(ON) inhibitors in combination with ivonescimab in patients with advanced RAS-mutated solid tumors • To define the RP2D for RAS(ON) inhibitors in combination with ivonescimab, with or without other anti-cancer agents, in patients with advanced RAS-mutated solid tumors
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]
- Decision date (initial)
- 2026-06-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Revolution Medicines Inc
External identifiers
- EU CT number
- 2025-524623-50-00
- ClinicalTrials.gov
- NCT07397338
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Safety, Dose response
• To evaluate the safety and tolerability of RAS(ON) inhibitors in combination with ivonescimab in patients with advanced RAS-mutated solid tumors
• To define the RP2D for RAS(ON) inhibitors in combination with ivonescimab, with or without other anti-cancer agents, in patients with advanced RAS-mutated solid tumors
Secondary objectives 1
- To characterize the PK of RAS(ON) inhibitors in combination with ivonescimab, with or without other anti-cancer agents, in patients with advanced RAS-mutated solid tumors. To evaluate preliminary efficacy of RAS(ON) inhibitors in combination with ivonescimab, with or without other anti-cancer agents, in patients with advanced RAS-mutated solid tumors To characterize the PK of ivonescimab in combination with RAS(ON) inhibitors, with or without other anti-cancer agents, in patients with advanced RAS-mutated solid tumors To evaluate the immunogenicity of ivonescimab
Conditions and MedDRA coding
Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 29.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A Research Study Testing New Cancer Medicines Used Alone or Together to Treat Solid Tumors Daraxonrasib, elironrasib, and zoldonrasib (called RAS(ON) inhibitors) are new study drugs being tested with ivonescimab (bi-specific antibody) to treat advanced cancers with a RAS mutation.
|
Not Applicable | None |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 2024-513087-26-00 | A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3) | Summit Therapeutics Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participants may be included in the study if they • are at least 18 years old. • have a RAS-mutated cancer that has spread or cannot be removed by surgery and at least one tumor that can be measured by scans. Some parts of the study are only open to participants with a specific RAS mutation type. • have adequate organ function.
Exclusion criteria 1
- Participants cannot be included in the study if they • have previously received certain medicines that directly target RAS, or certain immune or anti-VEGF therapies (cancer treatment that stops tumors from growing new blood vessels). • have any medical condition including a bleeding issue, or active infections that may interfere with the study medicine. • are pregnant or breastfeeding. • depending on the part of the study, participants may or may not have received previous treatment for their cancer.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- • Incidence of DLTs (Part 1 and Part 2 safety lead-ins only)
- • Incidence of AEs, TRAEs, SAEs, and clinically significant changes in laboratory test values and vital signs
Secondary endpoints 5
- • RAS(ON) inhibitor concentrations over time as applicable
- • ORR and DOR per RECIST v1.1
- • DCR, TTR and PFS per RECIST v1.1
- • Ivonescimab serum concentrations over time as applicable
- • Number and percentage of patients with detectable anti-ivonescimab antibody (ADA) at baseline and post treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD9682730 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 2205259.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10296948 · Product
- Active substance
- Ivonescimab
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Not Authorised
- MA holder
- SUMMIT THERAPEUTICS SUB, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Erbitux 5 mg/mL solution for infusion
PRD327539 · Product
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- L01FE01 — -
- Marketing authorisation
- EU/1/04/281/003
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- 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
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
Pemetrexed 25 mg/ml concentrate for solution for infusion
PRD3501399 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- PL 06831/0285
- MA holder
- GENUS PHARMACEUTICALS LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD669106 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 84223.00.00
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9891840 · Product
- Active substance
- RMC-6291
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9891841 · Product
- Active substance
- RMC-6291
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Not Authorised
- MA holder
- REVOLUTION MEDICINES INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD12862247 · 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
- 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
- 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 15
| Organisation | City, country | Duties |
|---|---|---|
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 12, Code 13, Other, Code 2, Interactive response technologies (IRT), Code 5, Data management, Code 8 |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Other |
| Atreo Inc. ORG-100045217
|
San Francisco, United States | Interactive response technologies (IRT) |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Laboratory analysis |
| Myonex LLC ORG-100047430
|
Horsham, United States | Other |
| Equicare Health Inc. ORG-100056113
|
Vancouver, Canada | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | On site monitoring, Code 12, Code 5 |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Laboratory analysis |
| Cellcarta Naperville LLC ORG-100042145
|
Naperville, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, Data management |
| Tempus AI Inc. ORG-100044006
|
Chicago, United States | Laboratory analysis |
Locations
7 EU/EEA countries · 53 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 22 | 6 |
| France | Authorised, recruitment pending | 48 | 14 |
| Germany | Authorised, recruitment pending | 28 | 2 |
| Greece | Authorised, recruitment pending | 14 | 3 |
| Italy | Authorised, recruitment pending | 48 | 13 |
| Spain | Authorised, recruitment pending | 48 | 12 |
| Sweden | Authorised, recruitment pending | 19 | 3 |
| Rest of world
United States
|
— | 118 | — |
Investigational sites
UZ Leuven
Respiratory Oncology Unit (Resp. Medicine), Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Antwerpen
Oncology, Drie Eikenstraat 655, 2650, Edegem
UZ Brussel
Oncology, Laarbeeklaan 101, 1090, Jette
Institut Jules Bordet
Lung Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Az Maria Middelares Gent
Pneumology, Buitenring-Sint-Denijs 30, 9000, Gent
Centre hospitalier universitaire de Liege
Oncology, Avenue De L'Hopital 1, 4000, Liege
Centre Leon Berard
Department of Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Medical Oncology department, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Gustave Roussy
n/a, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospices Civils De Lyon
Hôpital Louis Pradel, Department of Pulmonology, 59 Boulevard Pinel, 69500, Bron
Institut Regional Du Cancer De Montpellier
ICM Val d’Aurelle, Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Institut Curie
Institut Curie Paris Pneumology, 26 Rue D Ulm, 75005, Paris
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Francois Baclesse
Department of pneumology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Regional De Marseille
Centre d’Essais Précoces en Cancérologie de Marseille (CEPCM), 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Universitaire De Nantes
Oncology Medical department, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Oncopole Claudius Regaud
Medical Oncology Department, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Rennes
Pneumology Department, 2 Rue Henri Le Guilloux, 35000, Rennes
Hospital Foch
Medical Oncology, 40 Rue Worth, 92150, Suresnes
Institut De Cancerologie De L Ouest
Pays de Loire, Department of oncology, 15 Rue Andre Boquel, 49100, Angers
Katholisches Klinikum Bochum gGmbH
Clinic of Hematology, Oncology and Palliative Medicine, Gudrunstrasse 56, Grumme, Bochum
Goethe University Frankfurt
Medizinische Klinik II, Hämatologie/Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Athens Medical Center S.A.
Oncology Department Distomou, Distomou 5-7, 151 25, Maroussi
Metropolitan Hospital
4th Oncology Department, Ethnarchi Makariou 9, 185 47, Pireas
General Hospital Of Athens Alexandra
Oncology Department, Vassilissis Sofias Avenue 80, 115 28, Athens
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department U.O. Oncologia, Piazzale Spedali Civili 1, 25123, Brescia
I.F.O. Istituti Fisioterapici Ospitalieri
UOSD Clinical Trials Unit: Phase 1 and Precision Medicine, Via Elio Chianesi N 53, 00144, Rome
IRCCS Azienda Ospedaliera Metropolitana
Medical oncology, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Unita Sanitaria Locale Della Romagna
U.O. Oncologia, Dipartimento Onco-Ematologico, Viale Vincenzo Randi 5, 48121, Ravenna
Humanitas Mirasole S.p.A.
Operating Unit of Oncology and Hematology – Phase I Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department UOC Oncoematologia, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero-Universitaria Senese
Department UOC Immunoterapia Oncologica, Strada Delle Scotte 14, 53100, Siena
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department of Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Hospital Santa Maria Della Misericordia
SC-Oncologia Medica, Piazzale Giorgio Menghini 1, 06129, Perugia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Struttura Semplice Dipartimentale di Oncologia Toracica, Via Piero Maroncelli 40, 47014, Meldola
Istituto Europeo Di Oncologia S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità Operativa Complessa Fase 1, Largo Francesco Vito 1, 00168, Rome
Ospedale San Raffaele S.r.l.
Unità di Oncologia Medica, Via Olgettina 60, 20132, Milan
Hospital Universitario Quironsalud Madrid
Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Y Politecnico La Fe
Medical Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Fundacion Rioja Salud
Medical Oncology, Calle Piqueras 98, 26006, Logrono
Clinica Universidad De Navarra
Medical Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Hm Nou Delfos
Medical Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital De Jerez De La Frontera
Medical Oncology, Carretera De La Ronda Circunvalacion S/n, 11407, Jerez De La Frontera
Clinica Universidad De Navarra
Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Region Gaevleborg
Gävle sjukhus, Lungenheten, Rektorsgatan 1, 802 50, Gavle
Karolinska University Hospital
Tema Cancer, CKC, Fas 1-enheten Solna, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
Klinisk Forskningsenhet, VE Onkologi, VO Hematologi, Onkologi och Strålningsfysik, Entregatan 7, 222 42, Lund
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 75 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol_2025-524623-50_ELL_Public | 3.1 |
| Protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol_2025-524623-50_Public | 3.3 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6236_NLD_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6236_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6291_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-9805_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6236_DEU_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6236_ELL_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6236_ITA_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6236_SPA_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6236_SWE_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6291_DEU_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6291_ELL_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6291_ITA_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6291_NLD_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6291_SPA_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-6291_SWE_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-9805_DEU_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-9805_ELL_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-9805_FRA_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-9805_ITA_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-9805_NLD_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-9805_SPA_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_ Patient Diary RMC-9805_SWE_Public | 1.1 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_Patient Diary RMC-6236_FRA_Public | 1.0 |
| Protocol (for publication) | D4_RevMed_RMC-APEX-103_Patient Diary RMC-6291_FRA_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-APEX 103_Recruitment and Informed Consent Procedure_DEU_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-APEX 103_Recruitment Arrangements_GRC_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-APEX 103_Recruitment-Arrangements_BEL_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_RMC-APEX 103_Recruitment-Arrangements_ESP_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_RMC-APEX-103_Additional-Document_FRA_fra_Public | n/a |
| Recruitment arrangements (for publication) | K1_RMC-APEX-103_Recruitment-and-Informed-Consent-Procedure_FRA_eng_fra_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_RMC-APEX-103_Recruitment-Arrangements_SWE_swe_Public | n/a |
| Recruitment arrangements (for publication) | K1_RMC-APEX-103_Recruitment-Informed-Consent-Procedure_IT_English_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_RMC-APEX-103_General-Practitioner-Letter_FRA_fra_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_RMC-APEX-103_GP-Letter_IT_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_ICF_Optional-Tumor-Biopsy_DEU-deu_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main ICF_BEL_eng_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main ICF_BEL_fra_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main ICF_BEL_nld_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main_ICF_GRC_ell_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main-ICF_DEU_deu_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main-ICF_ESP_spa_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main-ICF_Italy_Italian_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main-ICF_Part-I_DEU_deu_DEU-deu_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main-ICF_SWE_swe_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main-ICF-Part I_FRA_fra_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Main-ICF-Part II_FRA_fra_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_PP ICF_BEL_eng_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_PP ICF_BEL_fra_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_PP ICF_BEL_nld_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Pregnancy_ICF_GRC_ell_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Pregnancy-ICF_DEU_deu_Public | 2 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Pregnancy-ICF_FRA_fra_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Pregnant Partner ICF_SWE_swe_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Pregnant-Partner-ICF_ESP_spa_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Pregnant-Partner-ICF_Italy_Italian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Privacy-ICF_Italy_Italian_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_TB-Progression-ICF_DEU-deu_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_RMC-APEX-103_Treatment-Beyond-Progression-ICF-Addendum_FRA_fra_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_RMC-APEX-103_Patient-card_FRA_eng_fra_Public | 1.0.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-APEX-103_Representative SmPC_Carboplatin_ENG | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-APEX-103_Representative SmPC_Cetuximab_ENG | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-APEX-103_Representative SmPC_Cisplatin_ENG | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_RevMed_RMC-APEX-103_Representative SmPC_Pemetrexed_ENG | n/a |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Lay Synopsis_2025-524623-50_FRA_BE_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_DEU_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_ELL_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_FRA_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_ITA_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_NLD_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_POL_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_SPA_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_RevMed_RMC-APEX-103_Protocol Synopsis_2025-524623-50_SWE_Public | 4.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-06 | Spain | Acceptable with conditions 2026-06-29
|
2026-06-29 |