Clinical trial • Phase I/II • Oncology|Respiratory
(chemical described in product record) for Non-small cell lung cancer|RAS‑mutated non-small cell lung cancer
Phase I/II trial of (chemical described in product record) for Non-small cell lung cancer|RAS‑mutated non-small cell lung cancer. open-label, adaptive.
Overview
- Trial Therapeutic Area
- Oncology|Respiratory
- Trial Disease
- Non-small cell lung cancer|RAS‑mutated non-small cell lung cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-03-2024
- First CTIS Authorization Date
- 25-06-2024
Trial design
open-label, adaptive Phase I/II trial in Netherlands, Spain, Italy and others.
- Open Label
- Yes
- Adaptive
- True, includes dose-escalation/safety lead-in elements (DLT assessment and dose-escalation rules / safety lead-in cohorts as indicated by primary endpoint on DLTs and a dose escalation simulation report document).
- Biomarker Stratified
- True, biomarker: RAS mutation (RAS‑mutated NSCLC)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 176
Eligibility
Recruits 176 Vulnerable population selected. Subject information and informed consent forms (ICFs) are provided (country-specific ICFs listed for NL, ES, IT, DE, FR, etc.) and there are pregnancy/pregnant-partner ICFs available. Participants are adults (≥18 years) so consent is provided by the participant; no assent procedures for minors are specified..
- Vulnerable Population
- Vulnerable population selected. Subject information and informed consent forms (ICFs) are provided (country-specific ICFs listed for NL, ES, IT, DE, FR, etc.) and there are pregnancy/pregnant-partner ICFs available. Participants are adults (≥18 years) so consent is provided by the participant; no assent procedures for minors are specified.
Inclusion criteria
- {"criterion_text":"- Patients that are at least 18 years old.\n- Patients that have NSCLC with certain RAS mutations.\n- Patients that have NSCLC that is unlikely to be cured and has spread to other body parts.\n- Patients that have received prior cancer treatment.\n- Patients that have at least one tumor lesion (an area of abnormal tissue) that can be measured.\n- Patients that have adequate organ function (bone marrow, liver, kidney)."}
Exclusion criteria
- {"criterion_text":"- 1. Participants that have primary brain and spinal cord tumor spreading to other body parts.\n- 2. Participants that have gastrointestinal problems that may affect absorption of RMC-6236.\n- 3. Participants that had any major surgery in the last 4 weeks.\n- 4. Participants that have have previously taken targeted therapy for RAS mutation.\n- 5. Participants that have any other medical condition that may interfere with the study drugs."}
Endpoints
Primary endpoints
- {"endpoint_text":"- • Incidence of DLTs (Part 1 and Part 2 Cohort 2 safety lead-in only)","definition_or_measurement_approach":"Incidence of dose-limiting toxicities (DLTs) assessed during the specified safety lead-in periods (Part 1 and Part 2 Cohort 2)."}
- {"endpoint_text":"- •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), and clinically significant changes detected by laboratory tests, ECGs, and vital signs monitoring."}
Secondary endpoints
- {"endpoint_text":"- • Concentrations of RMC-6236 in plasma over time and PK parameters as applicable.","definition_or_measurement_approach":"Plasma pharmacokinetic (PK) sampling of RMC-6236 over time with derivation of standard PK parameters (e.g., Cmax, AUC) as applicable."}
- {"endpoint_text":"- • ORR and DOR per RECIST v1.1","definition_or_measurement_approach":"Objective response rate (ORR) and duration of response (DOR) assessed according to RECIST v1.1 criteria."}
Recruitment
- Planned Sample Size
- 176
- Recruitment Window Months
- 17
- Consent Approach
- Informed consent obtained from participants (participants are adults ≥18). Country-specific subject information sheets and ICFs are provided (documents available in Dutch, Spanish, Italian, German, French, English, etc.). Separate pregnancy/pregnant-partner ICFs are available where applicable.
Geography
- Total Number Of Sites
- 42
- Total Number Of Participants
- 180
Netherlands
- Earliest CTIS Part Ii Submission Date
- 31-05-2024
- Latest Decision Or Authorization Date
- 14-08-2024
- Processing Time Days
- 75
- Number Of Sites
- 4
- Number Of Participants
- 36
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Dept. of pulmonology and tuberculosis
- Principal Investigator Name
- A.J. van der Wekken
- Principal Investigator Email
- a.j.van.der.wekken@umcg.nl
- Contact Person Name
- A.J. van der Wekken
- Contact Person Email
- a.j.van.der.wekken@umcg.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Department of Pulmonary Diseases
- Principal Investigator Name
- Egbert F. Smit
- Principal Investigator Email
- e.f.smit@lumc.nl
- Contact Person Name
- Egbert F. Smit
- Contact Person Email
- e.f.smit@lumc.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Clinical Research Unit
- Principal Investigator Name
- Gerrina Ruiter
- Principal Investigator Email
- cpm-cru@nki.nl
- Contact Person Name
- Gerrina Ruiter
- Contact Person Email
- cpm-cru@nki.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Medical Oncology
- Principal Investigator Name
- Hilde Nienhuis
- Principal Investigator Email
- oncostudies@umcutrecht.nl
- Contact Person Name
- Hilde Nienhuis
- Contact Person Email
- oncostudies@umcutrecht.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 29-05-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 33
- Number Of Sites
- 13
- Number Of Participants
- 36
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncologia
- Principal Investigator Name
- Pilar Garrido
- Principal Investigator Email
- pgarrido@salud.madrid.org
- Contact Person Name
- Pilar Garrido
- Contact Person Email
- pgarrido@salud.madrid.org
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncologia
- Principal Investigator Name
- David Lorente Estelles
- Principal Investigator Email
- dlorente@fivo.org
- Contact Person Name
- David Lorente Estelles
- Contact Person Email
- dlorente@fivo.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Maria Rosario Garcia Campelo
- Principal Investigator Email
- ma.rosario.garcia.campelo@sergas.es
- Contact Person Name
- Maria Rosario Garcia Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncologia
- Principal Investigator Name
- Marta Domenech Viñolas
- Principal Investigator Email
- mdomenechv@iconcologia.net
- Contact Person Name
- Marta Domenech Viñolas
- Contact Person Email
- mdomenechv@iconcologia.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncologia
- Principal Investigator Name
- Oscar Juan Vidal
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Oscar Juan Vidal
- Contact Person Email
- juan_osc@gva.es
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncologia
- Principal Investigator Name
- Jorge Bartolome
- Principal Investigator Email
- jorge.bartolome@salud.madrid.org
- Contact Person Name
- Jorge Bartolome
- Contact Person Email
- jorge.bartolome@salud.madrid.org
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Vanesa Gutierrez
- Principal Investigator Email
- vgutierrezcald@gmail.com
- Contact Person Name
- Vanesa Gutierrez
- Contact Person Email
- vgutierrezcald@gmail.com
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Oncologia
- Principal Investigator Name
- Miguel Fernandez De Sanmamed
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernandez De Sanmamed
- Contact Person Email
- msanmamed@unav.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncologia
- Principal Investigator Name
- Bernard Doger de Speville Uribe
- Principal Investigator Email
- bernard.doger@startmadrid.com
- Contact Person Name
- Bernard Doger de Speville Uribe
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncologia
- Principal Investigator Name
- Alejandro Falcon
- Principal Investigator Email
- afalconglez@gmail.com
- Contact Person Name
- Alejandro Falcon
- Contact Person Email
- afalconglez@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncologia
- Principal Investigator Name
- Patricia Iranzo
- Principal Investigator Email
- piranzo@vhio.net
- Contact Person Name
- Patricia Iranzo
- Contact Person Email
- piranzo@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncologia
- Principal Investigator Name
- Luis Paz-Ares Rodriguez
- Principal Investigator Email
- luis.paz-ares@salud.madrid.org
- Contact Person Name
- Luis Paz-Ares Rodriguez
- Contact Person Email
- luis.paz-ares@salud.madrid.org
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Oncologia
- Principal Investigator Name
- Miguel Fernandez De Sanmamed
- Principal Investigator Email
- msanmamed@unav.es
- Contact Person Name
- Miguel Fernandez De Sanmamed
- Contact Person Email
- msanmamed@unav.es
Italy
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 26-06-2024
- Processing Time Days
- 27
- Number Of Sites
- 7
- Number Of Participants
- 36
Sites
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Unità Clinica Fase 1 – UO Oncologia di Ravenna
- Principal Investigator Name
- Manolo D’Arcangelo
- Principal Investigator Email
- manolo.darcangelo@auslromagna.it
- Contact Person Name
- Manolo D’Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- UOSD Clinical Trial Unit Phase 1and Precision Medicine
- Principal Investigator Name
- Lorenza Landi
- Principal Investigator Email
- lorenza.landi@ifo.it
- Contact Person Name
- Lorenza Landi
- Contact Person Email
- lorenza.landi@ifo.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Department: SC Oncologia Falck
- Principal Investigator Name
- Salvatore Siena
- Principal Investigator Email
- salvatore.siena@ospedaleniguarda.it
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@ospedaleniguarda.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Angelo Delmonte
- Principal Investigator Email
- angelo.delmonte@irst.emr.it
- Contact Person Name
- Angelo Delmonte
- Contact Person Email
- angelo.delmonte@irst.emr.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology and Hematology
- Principal Investigator Name
- Sara Cresta
- Principal Investigator Email
- sara.cresta@istitutotumori.mi.it
- Contact Person Name
- Sara Cresta
- Contact Person Email
- sara.cresta@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Department: SSD Oncologia polmonare-A.O.U. San Luigi Gonzaga - Orbassano
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Unità Operativa Complessa Fase 1
- Principal Investigator Name
- Gennaro Daniele
- Principal Investigator Email
- gennaro.daniele@policlinicogemelli.it
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
Germany
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 06-08-2024
- Processing Time Days
- 53
- Number Of Sites
- 7
- Number Of Participants
- 36
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik mit Schwerpunkt Onkologie, Hämatologie und Tumorimmunologie
- Principal Investigator Name
- Damian Rieke
- Principal Investigator Email
- damian.rieke@charite.de
- Contact Person Name
- Damian Rieke
- Contact Person Email
- damian.rieke@charite.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik I für Innere Medizin
- Principal Investigator Name
- Jürgen Wolf
- Principal Investigator Email
- juergen.wolf@uk-koeln.de
- Contact Person Name
- Jürgen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik und Poliklinik I
- Principal Investigator Name
- Martin Wermke
- Principal Investigator Email
- martin.wermke@uniklinikum-dresden.de
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
- Site Name
- Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
- Department Name
- Klinik für Lungen- & Bronchialheilkunde
- Principal Investigator Name
- Kato Kambartel
- Principal Investigator Email
- kambartel@bethanienmoers.de
- Contact Person Name
- Kato Kambartel
- Contact Person Email
- kambartel@bethanienmoers.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Medizinische Klinik II
- Principal Investigator Name
- Martin Sebastian
- Principal Investigator Email
- sebastian@med.uni-frankfurt.de
- Contact Person Name
- Martin Sebastian
- Contact Person Email
- sebastian@med.uni-frankfurt.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Universitätsklinikum Heidelberg
- Principal Investigator Name
- Farastuk Bozorgmehr
- Principal Investigator Email
- farastuk.bozorgmehr@med.uni-heidelberg.de
- Contact Person Name
- Farastuk Bozorgmehr
- Contact Person Email
- farastuk.bozorgmehr@med.uni-heidelberg.de
- Site Name
- Lungenfachklinik Immenhausen
- Principal Investigator Name
- Achim Rittmeyer
- Principal Investigator Email
- a.rittmeyer@lungenfachklinik-immenhausen.de
- Contact Person Name
- Achim Rittmeyer
- Contact Person Email
- a.rittmeyer@lungenfachklinik-immenhausen.de
France
- Earliest CTIS Part Ii Submission Date
- 30-05-2024
- Latest Decision Or Authorization Date
- 01-07-2024
- Processing Time Days
- 32
- Number Of Sites
- 11
- Number Of Participants
- 36
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Audrey RABEAU
- Principal Investigator Email
- Rabeau.audrey@iuct-oncopole.fr
- Contact Person Name
- Audrey RABEAU
- Contact Person Email
- Rabeau.audrey@iuct-oncopole.fr
- Site Name
- Centre Francois Baclesse
- Principal Investigator Name
- Hubert CURCIO
- Principal Investigator Email
- h.curcio@baclesse.unicancer.fr
- Contact Person Name
- Hubert CURCIO
- Contact Person Email
- h.curcio@baclesse.unicancer.fr
- Site Name
- Hospital Foch
- Principal Investigator Name
- Jaafar BENNOUNA
- Principal Investigator Email
- j.bennouna@hopital-foch.com
- Contact Person Name
- Jaafar BENNOUNA
- Contact Person Email
- j.bennouna@hopital-foch.com
- Site Name
- Institut Bergonie
- Principal Investigator Name
- Sophie COUSIN
- Principal Investigator Email
- s.cousin@bordeaux-unicancer.fr
- Contact Person Name
- Sophie COUSIN
- Contact Person Email
- s.cousin@bordeaux-unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Principal Investigator Name
- Alexis CORTOT
- Principal Investigator Email
- Alexis.cortot@chru-lille.fr
- Contact Person Name
- Alexis CORTOT
- Contact Person Email
- Alexis.cortot@chru-lille.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP (Medical Oncology in Early Drug Development Department)
- Principal Investigator Name
- Anas GAZZAH
- Principal Investigator Email
- anas.gazzah@gustaveroussy.fr
- Contact Person Name
- Anas GAZZAH
- Contact Person Email
- anas.gazzah@gustaveroussy.fr
- Site Name
- Hospices Civils De Lyon
- Principal Investigator Name
- Michael DURUISSEAUX
- Principal Investigator Email
- Michael.duruisseaux@chu-lyon.fr
- Contact Person Name
- Michael DURUISSEAUX
- Contact Person Email
- Michael.duruisseaux@chu-lyon.fr
- Site Name
- Institut Curie
- Principal Investigator Name
- Pauline DU RUSQUEC
- Principal Investigator Email
- Pauline.durusquec@curie.fr
- Contact Person Name
- Pauline DU RUSQUEC
- Contact Person Email
- Pauline.durusquec@curie.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Principal Investigator Name
- Jeanne CHEN
- Principal Investigator Email
- Jeanne.chen@chu-nantes.fr
- Contact Person Name
- Jeanne CHEN
- Contact Person Email
- Jeanne.chen@chu-nantes.fr
- Site Name
- Centr Georges Francois Leclerc
- Principal Investigator Name
- François GHIRINGHELLI
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- François GHIRINGHELLI
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Centre Francois Baclesse (additional listing)
Sponsor
Primary sponsor
- Full Name
- Revolution Medicines Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Contract Research Organization, Clinical Database Management, Pharmacovigilance services.
Third parties
- {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"code 9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Myonex LLC","duties_or_roles":"Clinical Supply","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Sherpa Clinical Packaging LLC","duties_or_roles":"Collect and read ECG scans","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Aperio Clinical Outcomes LLC","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"Collect and read ECG scans","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel & Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"Stats Programing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Tempus Labs Inc.","duties_or_roles":"code 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Contract Research Organization, Clinical Database Management, Pharmacovigilance services.","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic drug diaries","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA Analysis","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- DARAXONRASIB (RMC-6236)
- Active Substance
- (chemical described in product record)
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 1
- Maximum Dose
- 400 mg
- Investigational Product Name
- KEYTRUDA (pembrolizumab)
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SOLUTION FOR INFUSION (intravenous infusion)
- Route
- Intravenous infusion
- Authorisation Status
- 2
- Maximum Dose
- 200 mg
- Investigational Product Name
- Pemetrexed (various brands)
- Active Substance
- PEMETREXED
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- 2
- Maximum Dose
- 500 mg total (maxTotalDoseAmount indicates 500 mg total or 23.8 mg/m2 daily as provided)
- Investigational Product Name
- Cisplatin (various brands)
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- 2
- Maximum Dose
- 75 mg (maxTotalDoseAmount 75 or maxDailyDoseAmount 3.57 mg/m2 as provided)
- Investigational Product Name
- Carboplatin (various brands)
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- 2
- Maximum Dose
- 750 mg (maxTotalDoseAmount 750 or maxDailyDoseAmount as provided)
- Combination Treatment
- Yes
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