Trial results for a Phase 1 study investigating sotorasib in combination with VIC-1911 for KRAS G12C-mutant non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-05-01. The study, which enrolled 3 participants, was terminated and reported 0 objective responses across all treatment arms. For the combination therapy, the median progression-free survival was 47 days.
Background
Sotorasib is a targeted therapy for KRAS G12C-mutant non-small cell lung cancer. This trial investigated sotorasib in combination with VIC-1911, an aurora kinase A inhibitor, for the treatment of this specific type of lung cancer.
Trial design
The Phase 1 study (NCT05374538) was titled "VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer." It was designed as a Phase 1a/1b study to evaluate VIC-1911 as monotherapy and in combination with sotorasib. The trial enrolled 3 participants with KRAS G12C-mutant non-small cell lung cancer. The study was ultimately terminated.
Key results
The trial reported on several key measurements for safety and efficacy:
- For "Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)":
- In the "Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy" group, 0 Participants experienced these events.
- In the "Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy" group, 3 Participants experienced these events.
- In the "Expansion Phase, Cohort 2a: VIC-1911 Monotherapy" group, 0 Participants experienced these events.
- In the "Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy" group, 0 Participants experienced these events.
- In the "Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy" group, 0 Participants experienced these events.
- For "Objective Response Rate", 0 Participants achieved an objective response across all evaluated groups (Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy; Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy; Expansion Phase, Cohort 2a: VIC-1911 Monotherapy; Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy; and Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy).
- For "Disease Control Rate" in the "Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy" group, 0 Participants achieved disease control.
- For "Progression-Free Survival" in the "Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy" group, the median was 47 days.
What this means
The termination of this Phase 1 study, combined with the low enrollment of 3 participants and the reported 0 objective responses across all arms, indicates that the combination of VIC-1911 and sotorasib did not demonstrate sufficient early efficacy or safety to proceed. The median progression-free survival of 47 days in the combination therapy arm also suggests limited clinical benefit in this small cohort of patients with KRAS G12C-mutant non-small cell lung cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05374538, titled "VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer," were posted on 2025-05-01 on clinicaltrials.gov.