A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
1. Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV Non-squamous NSCLC disease.
2. Has KRAS G12C mutation confirmed by central laboratory.
3. Measurable disease according to RECIST 1.1.
4. An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
5. Adequate organ function.
6. Life expectancy ≥3 months in the opinion of the Investigator
7. Male and female participants of reproductive potential must agree to use effective contraception during and for 6 months after treatment
You may not be if
1. Has another known driver mutation with approved first-line targeted therapy.
2. Participants with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
3. Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.
4. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
5. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
6. Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease.
7. Any condition that, in the opinion of the Investigator, would interfere with participation or study results
Clareo Health | A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation
