The trial NCT06162221 is an open-label, multicenter Phase?1/2 platform interventional study evaluating novel RAS(ON) inhibitors in adults with advanced or metastatic non-small cell lung cancer (NSCLC) harbouring documented RAS gene mutations (e.g., KRAS, NRAS, HRAS). The primary objective is to establish recommended Phase?2 dose (RP2D) and assess objective response rate (ORR) across multiple sub-protocols. Eligible participants have ECOG performance status 0–1, adequate organ function, confirmed RAS-mutation and non-curatively treatable advanced or metastatic disease. Molecular RAS-mutation status is confirmed at screening. Patients are enrolled non-randomised in parallel cohorts (e.g., RMC-6291 ± RMC-6236 + pembrolizumab ± chemotherapy; RMC-6236 + pembrolizumab ± chemotherapy; RMC-9805 ± RMC-6236 + pembrolizumab ± chemotherapy; RMC-9805 monotherapy). Key secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety/tolerability profiles.
This study involves adults with advanced non-small cell lung cancer (NSCLC) whose tumors harbour RAS gene mutations (e.g., KRAS, NRAS or HRAS). The investigational RAS(ON) inhibitors are being evaluated for safety, tolerability and early signs of anti-tumour activity. Participants receive the study drugs either as monotherapy or combined with standard treatment such as immunotherapy or chemotherapy. Additional objectives include pharmacokinetics (how the drug behaves in the body) and duration of response.
