Phase II Study of Sotorasib AMG510 for Unresectable Stage III KRAS p.G12C Non-Small Cell Lung Cancer Patients Ineligible for Chemo-radiotherapy

What this Trial Is About

Researchers are evaluating AMG510 Sotorasib in adults with unresectable stage III non-small cell lung cancer NSCLC that has the KRAS p.G12C mutation and who cannot have chemo-radiotherapy. This open-label, non-randomized, phase II study aims to assess the treatments effect on progression-free survival at 12 months in 43 patients across multiple centers. The trial includes patients with specific lung cancer stages and medical conditions preventing standard chemo-radiotherapy. Participants will receive AMG510 tablets at a dose of 960 mg once daily for two 4-week cycles during an induction phase. Those with stable disease, partial response, or complete response after induction will continue AMG510 once daily during a post-induction treatment phase. Treatment continues until disease progression, unacceptable side effects, a decision to stop by patient or doctor, or death. The study plans patient enrollment over five and a half years, with treatment lasting up to 1.5 years. During the trial, participants will undergo regular assessments including PET-CT scans, brain imaging, and tumor evaluations based on standard criteria. Researchers will monitor progression-free survival, overall response rate, overall survival, sites of disease failure, and treatment side effects. Safety will be observed from consent through 30 days after treatment ends. Follow-up will continue for two years after treatment to track long-term outcomes and survival.

Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy