Clinical trial · Interventional
Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies
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
NCT05054725CI-TRIAL-00100217completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RMC-4630 | Drug | Vociprotafib | ALIAS |
| Sotorasib | Drug | Sotorasib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RMC-4630 and sotorasib, Safety Run-in
- description
- Safety Run-In: RMC-4630 and sotorasib
- interventionNames
- Drug: RMC-4630
- Drug: Sotorasib
- type
- EXPERIMENTAL
- label
- RMC-4630 and sotorasib, Expansion
- description
- Dose Expansion: RMC-4630 and sotorasib
- interventionNames
- Drug: RMC-4630
- Drug: Sotorasib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) as Assessed Per RECIST v1.1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.