Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Pembrolizumab

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

RMC-6291 (BID) and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W-Q4W)

RMC-6236 (QD) and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W-Q4W)

RMC-6291

RMC-6236

Revolution Medicines

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

The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on NSCLC.

This is an open-label platform Phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC), and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with KRAS or RAS mutations will be specified in each subprotocol.

Subprotocol A is an open-label, multicenter, Phase 1b/2 study of RMC-6291 in combination with pembrolizumab, with or without chemotherapy, in patients with KRAS G12C-mutated advanced solid tumors.

Subprotocol B is an open-label, multicenter, Phase1b/2 study of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with RAS-mutated non-small cell lung cancer (NSCLC)

Each subprotocol consists of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.

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

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

Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vital signs

Number of participants with dose limiting toxicities

Maximum observed blood concentration of each drug per subprotocol

Time to reach maximum blood concentration of each drug per subprotocol

Area under the concentration-time curve of each drug per subprotocol

Revolution Medicines, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of RAS(ON) Inhibitor Combinations in Patients With Advanced RAS-mutated NSCLC	NCT06162221	Non-Small Cell ... KRAS, NRAS, HRA... KRAS G12C-mutat... Lung Cancer Sta...	RMC-6291 RMC-6236 Pembrolizumab Cisplatin Carboplatin Pemetrexed	18 Years -	Revolution Medicines, Inc.
Study of RAS(ON) Inhibitor Combinations in Patients With Advanced RAS-mutated NSCLC	NCT06162221	Non-Small Cell ... KRAS, NRAS, HRA... KRAS G12C-mutat... Lung Cancer Sta...	RMC-6291 RMC-6236 Pembrolizumab Cisplatin Carboplatin Pemetrexed	18 Years -	Revolution Medicines, Inc.

Spots Global Cancer Trial Database for lung cancer stage iv, advanced solid tumor, cancer