Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy
Trial Parameters
Brief Summary
Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.
Eligibility Criteria
Inclusion Criteria: * 1\. Male or female, aged ≤ 80 years old * 2\. ECOG performance status of 0-1 * 3\. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology. * 4\. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy. * 5\. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC. * 6\. Having a life expectancy ≥ 12 weeks * 7\. Patients must be ineligible for concurrent chemo-radiotherapy because of: 1. Tumor size ≥ 5 cm and lymph node N2 involvement 2. The target lesion has to be bulky disease and/or more than 35% of the total volume of the two lungs should receive more than 20 Gy (V20) or inadequate pulmonary function 3. Interstitial Lung diseases 4. Prior treatment with thoracic radiotherapy for any reason 5. Or under de