Phase 2
N=47
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05054725 ↗Enrolled (actual)
47
Serious AEs
97.9%
Results posted
Jan 2026
Primary outcome: Primary: Objective Response Rate (ORR) as Assessed Per RECIST v1.1 — 0; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RMC-4630 (Drug); Sotorasib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Revolution Medicines, Inc.
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) as Assessed Per RECIST v1.1 |
0; 11 | — |
| SECONDARY Clinically Significant Changes in Vital Signs |
0; 0 | — |
| SECONDARY Clinically Significant Changes in Laboratory Tests |
1; 5; 2; 5; 0; 5 | — |
| SECONDARY Clinically Significant Changes in ECGs |
0; 0 | — |
| SECONDARY Trough and Approximate Peak Concentrations of RMC-4630 |
21.04; 27.55; 187.64; 276.29; 24.75; 22.34 | — |
| SECONDARY Trough and Approximate Peak Concentrations of Sotorasib |
615.6; 375.4; 6009.3; 4603.3; 674.7; 336.4 | — |
| SECONDARY Duration of Response (DOR) as Assessed Per RECIST v1.1 |
12.19 | — |
| SECONDARY Disease Control Rate (DCR) as Assessed Per RECIST v.1.1 |
3; 34 | — |
| SECONDARY Progression-free Survival (PFS) as Assessed Per RECIST v1.1 |
2.64; 7.66 | — |
| SECONDARY Overall Survival (OS) |
5.80; 12.45 | — |
| SECONDARY Incidence, Nature and Severity of TEAEs, SAEs |
3; 43; 4; 43 | — |
Summary
The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05054725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.