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Chemotherapy

RAS Inhibitors + Standard Treatments for Lung Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Revolution Medicines, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing new drugs that target a protein called RAS in combination with standard treatments. The goal is to see if these drugs are safe, well-tolerated, and effective at treating tumors

Who is the study for?
Adults over 18 with advanced RAS-mutated NSCLC who have already tried standard treatments can join this trial. They should be relatively active and healthy (ECOG PS 0-1) with their major organs working well. Subprotocol A is specific to those with KRAS G12C mutations, while Subprotocol B is for broader RAS mutations.
What is being tested?
The study tests new drugs called RMC-6291 and RMC-6236 in combination with standard cancer treatments like Cisplatin, Pemetrexed, Carboplatin, or Pembrolizumab. It aims to see how safe they are together and if they help against lung cancer.
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to the drugs, issues from the chemotherapy such as nausea or hair loss, kidney or liver function changes due to drug interactions, and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced or has spread, cannot be removed by surgery, and has a specific KRAS G12C mutation.
Select...
My lung cancer is advanced or has spread and tests show a RAS mutation.
Select...
I am 18 years old or older.
Select...
I can carry out all my daily activities without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Dose limiting toxicities
Secondary study objectives
AUC
Cmax
DOR
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subprotocol B: RAS-mutated NSCLCExperimental Treatment5 Interventions
RMC-6236 (QD) and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W-Q4W)
Group II: Subprotocol A: KRAS G12C-Mutated Solid TumorsExperimental Treatment5 Interventions
RMC-6291 (BID) and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W-Q4W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120
Pembrolizumab
2017
Completed Phase 3
~2810
Pemetrexed
2014
Completed Phase 3
~5550

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor
12 Previous Clinical Trials
2,730 Total Patients Enrolled
Revolution MedicinesStudy DirectorRevolution Medicines
~235 spots leftby Jun 2027
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