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

First listed

Dec 8, 2023

Start date

Jan 18, 2024

Status verified

Jun 2026

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 (28)

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