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Chemotherapy

Subprotocol B: RAS-mutated NSCLC for Non-Small Cell 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

Study 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.Check my eligibility

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.See study design

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.

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My lung cancer is advanced or has spread and tests show a RAS mutation.

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I am 18 years old or older.

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I can carry out all my daily activities without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Dose limiting toxicities

Secondary outcome measures

AUC

Cmax

DOR

+2 more

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

~1940

Carboplatin

2014

Completed Phase 3

~6670

Pembrolizumab

2017

Completed Phase 2

~2010

Pemetrexed

2014

Completed Phase 3

~5250

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Revolution Medicines, Inc.Lead Sponsor

10 Previous Clinical Trials

1,710 Total Patients Enrolled

Revolution MedicinesStudy DirectorRevolution Medicines

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently open?

"Indeed, the information provided on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible candidates. The initial posting of the study occurred on January 1st, 2024, and it was most recently updated on January 3rd, 2024. To complete the trial successfully, a total of 352 participants will be recruited from two designated sites."

Answered by AI

What is the current number of subjects enrolled in this medical study?

"Indeed, the information on clinicaltrials.gov verifies that this research project is actively seeking eligible participants. The initial posting of the clinical trial was made on January 1st, 2024, and the most recent update occurred on January 3rd, 2024. A total of 352 patients will be enrolled in this study across two designated sites."

Answered by AI

What is the primary goal of this medical study?

"The main focus of this clinical trial, evaluated over a span of up to 5 years, is determining dose-limiting toxicities. Secondary objectives include measuring Tmax (time taken to achieve peak blood concentration for each drug per subprotocol), AUC (area under the concentration-time curve for each drug per subprotocol), and ORR (overall response rate based on RECIST v1.1 criteria)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study of RAS(ON) Inhibitor Combinations in Patients With Advanced RAS-mutated NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06162221.

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