Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients
← catalyst calendarSponsored by Verastem, Inc. (industry) · VSTM — their whole pipeline →. With Amgen.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
153estimated
Sites
35
Countries
Belgium, France, Netherlands +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-04-12 | actual | When the study began enrolling |
| Primary completion | Jun 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2021-10-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Non Small Cell Lung Cancer
- KRAS Activating Mutation
Interventions
- Drug: avutometinib and sotorasib — also filed as AMG 510, LUMAKRAS™, VS-6766
- Drug: avutometinib and sotorasib and defactinib — also filed as AMG 510, LUMAKRAS™, VS-6766, VS-6063
Primary outcomes
what the primary-completion date above is the date OFPart A: To determine RP2D for avutometinib in combination with sotorasib and the Alt-RP2D for avutometinib in combination with sotorasib and defactinib
measured From start of treatment to confirmation of RP2D; 28 days
Part B: To determine the efficacy of the RP2D and/or Alt-RP2D identified from Part A
measured From start of treatment to confirmation of response; 16 weeks
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