Informations générales (source: ClinicalTrials.gov)
A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Interventional
Phase 1/Phase 2
Revolution Medicines, Inc. (Voir sur ClinicalTrials)
janvier 2024
décembre 2028
17 octobre 2024
The purpose of this platform study is to evaluate the safety, tolerability,
pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors
combined with Standard(s) of Care (SOC) or with each other.
The first two subprotocols include the following:
Subprotocol A: RMC-6291 + SOC Subprotocol B: RMC-6236 + SOC
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:37 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - 14076 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - 21079 - Dijon - Bourgogne-Franche-Comté - France | Contact (sur clinicalTrials) | ||||
| CHU de Lille Institut Cœur Poumon - 59037 - Lille - Hauts-de-France - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes - 44093 - Nantes - Hauts-de-France - France | Contact (sur clinicalTrials) | ||||
| EDOG - Institut Bergonié - 33000 - Bordeaux - Nouvelle-Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - Hôpital Louis Pradel - 69500 - Bron - Auvergne-Rhône-Alpes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion criteria:
All Patients (unless otherwise noted):
- ≥ 18 years of age
- ECOG PS is 0 to 1
- Adequate organ function as outlined by the study
- Received prior standard therapy appropriate for tumor type and stage
- Must have pathologically documented, locally advanced or metastatic KRAS
G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol
A)
- Must have pathologically documented, locally advanced or metastatic RAS-mutated
NSCLC (Subprotocol B)
All Patients (unless otherwise noted):
- ≥ 18 years of age
- ECOG PS is 0 to 1
- Adequate organ function as outlined by the study
- Received prior standard therapy appropriate for tumor type and stage
- Must have pathologically documented, locally advanced or metastatic KRAS
G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol
A)
- Must have pathologically documented, locally advanced or metastatic RAS-mutated
NSCLC (Subprotocol B)
All Patients:
- Primary central nervous system (CNS) tumors
- Impaired gastrointestinal (GI) function that may significantly alter the absorption
of RMC drugs
- Major surgery < 28 days of first dose
- Active or history of interstitial lung disease (ILD) or pneumonitis requiring
steroids
Other inclusion/exclusion criteria may apply.