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NCT05074810 (Avutometinib in 1L or 2L KRAS-G12C-mutant NSCLC patients): BVCT ex-ante prediction vs. reported outcome

On 26 Apr 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 29 Dec 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (superior to chemotherapy) and commercially insufficient.

Clinical Trial

NCTID
NCT05074810
Acronym
RAMP203
Drug Name
Avutometinib (VS-6766)
Drug MoA
RAF/MEK clamp or MEK inhibitor?
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
1L or 2L KRAS-G12C-mutant NSCLC patients
Human Patients
153
Sponsor
Verastem
Phase
Phase 1 Phase 2

Prediction of , index 1991

Prospective Prediction
Prediction Index
1991
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS for avutometinib + sotorasib + defactinib moderately superior to chemotherapy for KRAS G12C inhibitor exposed patients) partial SUCCESS (commercially maybe sufficient yet weak clinical benefit in OS for avutometinib + sotorasib at most slightly superior to chemotherapy for KRAS G12C inhibitor naïve patients) partial FAILURE (commercially insufficient clinical benefit in OS for avutometinib + sotorasib + defactinib inferior to chemotherapy for KRAS G12C inhibitor naïve patients)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS for both avutometinib + sotorasib and avutometinib + sotorasib + defactinib moderately superior to chemotherapy for KRAS G12C inhibitor naïve/exposed patients)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
247 days in advance
Readout Data Interpretation
avutometinib + sotorasib doublet achieved 40% ORR (12/30) and 11.1 months mPFS in 1L KRAS_G12C-mutant NSCLC patients, which are superior to chemotherapy mono therapy's 25-35% ORR and 4-6 months mPFS (see add'l link below); further development is discontinued to refocus resources on other assets
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior to chemotherapy) and commercially insufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1/2 Study of Avutometinib (VS-6766) in Combination With Sotorasib With or Without Defactinib in Patients With KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
153
Lead sponsor
Verastem, Inc.
Conditions
Non Small Cell Lung Cancer; KRAS Activating Mutation
Interventions
DRUG: avutometinib and sotorasib; DRUG: avutometinib and sotorasib and defactinib
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-04-12
Primary completion
2026-06
Completion
2027-04
Primary outcomes
  • Part A: To determine RP2D for avutometinib in combination with sotorasib and the Alt-RP2D for avutometinib in combination with sotorasib and defactinib (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 (From start of treatment to confirmation of response; 16 weeks)

NCT05074810 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials