ClinTrial Refer

Trial Acronym
RMC-4630

Registration Number
NCT05054725

Scientific Title
A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in
subjects with KRASG12C mutant NSCLC

-  Subject must be =18 years of age.
-  Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed)

-  Primary central nervous system (CNS) tumors
-  Known or suspected leptomeningeal or brain metastases or spinal cord compression
-  Clinically significant cardiac disease
-  Known impairment of GI function that would alter the absorption
-  Active autoimmune disease requiring systemic treatment within past 2 years
-  History of severe allergic reactions to any of the study intervention components
-  Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
-  Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor

Revolution Medicines, Inc.

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT05054725

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT05054725

Secondary IDs
RMC-4630-03

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 2

Minimum Age
18

Maximum Age
100

Date Registered
07/07/2022

Date Closed
N/A

Status
Closed

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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