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

Korábbi kezelés

• Has another known driver mutation with approved first-line targeted therapy.
• Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or pan-RAS inhibitors.

Más betegség

• History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
• Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.
• Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease.
• Any condition that, in the opinion of the Investigator, would interfere with participation or study results

Egyéb

• 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.

• 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.
• Has KRAS G12C mutation confirmed by central laboratory.
• Measurable disease according to RECIST 1.1.
• An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
• Adequate organ function.
• Life expectancy ≥3 months in the opinion of the Investigator
• Male and female participants of reproductive potential must agree to use effective contraception during and for 6 months after treatment