Clinical Trial 23183

• Overview

  Study Title:

  A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)

  Objective:

  Subprotocol A Primary Objectives * To evaluate the safety and tolerability of RMC-6291 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced KRASG12C-mutated solid tumors * To define the RP2DS for RMC-6291 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced KRASG12C-mutated solid tumors Subprotocol A Secondary Objectives * To characterize the plasma PK profile of RMC-6291 in combination with pembrolizumab in patients with advanced KRASG12C-mutated solid tumors * To evaluate preliminary antitumor activities of RMC-6291 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced KRASG12C mutated solid tumors, including NSCLC Subprotocol B Primary Objectives * To evaluate the safety and tolerability of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS-mutated NSCLC * To estimate the RP2DS for RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS-mutated NSCLC Subprotocol B Secondary Objectives * To characterize the blood PK profile of RMC-6236 in combination with pembrolizumab in patients with advanced RAS-mutated NSCLC * To evaluate preliminary antitumor effects of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS-mutated NSCLC

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

  Medications:

  Alimta (Pemetrexed); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); RMC-6236 (); RMC-6291 (); RMC-9805 (); carboplatin (); cisplatin ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • ≥ 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).
  • Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C).
  • Additional criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Primary central nervous system (CNS) tumors.
  • Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs.
  • Major surgery > Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids.
  • Additional criteria may apply.

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