Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

Conditions

• KRAS G12C-mutated Solid Tumors, Lung Cancer
• KRAS, NRAS, HRAS-mutated NSCLC
• Lung Cancer Stage IV, Advanced Solid Tumor, Cancer
• Non-Small Cell Lung Cancer, NSCLC
• RAS G12D-mutated NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RMC-6291 — DRUG
  Oral tablet
• RMC-6236 — DRUG
  Oral tablet
• Pembrolizumab — DRUG
  IV Infusion
• Cisplatin — DRUG
  IV Infusion
• Carboplatin — DRUG
  IV Infusion
• Pemetrexed — DRUG
  IV infusion
• RMC-9805 — DRUG
  Oral Tablet

Study Details

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805

Key Dates

Start date

Jan 18, 2024

Status verified

Jun 2025

Primary completion

Jun 30, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

616 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Subprotocol A: KRAS G12C-Mutated Solid Tumors
  RMC-6291 (BID), RMC-6236 (QD), and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W)
• Experimental: Subprotocol B: RAS-mutated NSCLC
  RMC-6236 (QD) and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W)
• Experimental: Subprotocol C: RAS G12D-mutated NSCLC
  RMC-9805 (QD or BID), RMC-6236 (QD), and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W).
• Experimental: Subprotocol D: RAS G12D-mutated NSCLC
  RMC-9805 (QD)

Primary Outcome Measure

Adverse events [ Time Frame: Up to 5 years ]

Central Contacts

• Revolution Medicines
  1-844-2-REVMED
  [email protected]

Locations (26)

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