A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation

Prior treatment

• Prior treatment with KRAS G12C inhibitors, FAK inhibitors, or immune checkpoint inhibitors
• Has received a live vaccine within 30 days before first dose of study drug

Other illness

• Has uncontrolled cardiovascular disease, active severe infection, interstitial lung disease, or autoimmune disease requiring systemic therapy
• Has history of another malignancy within 5 years, except those curatively treated and considered low risk (e.g., basal cell carcinoma, cervical carcinoma in situ)
• Has gastrointestinal conditions that may interfere with absorption of oral drugs (if applicable)
• Has known active hepatitis B, hepatitis C, or HIV infection
• Has psychiatric or substance abuse disorders that would interfere with study compliance
• Any condition that, in the opinion of the Investigator, would interfere with participation or study results

Lab values

• Has another known driver mutation with approved targeted therapy (e.g., EGFR, ALK, ROS1)

Other

• Has other histological subtypes of NSCLC (e.g., small cell or neuroendocrine)
• Has active or untreated CNS metastases or carcinomatous meningitis
• Pregnant or breastfeeding women
• Is participating in another interventional clinical study

• Able and willing to provide informed consent and comply with study requirements
• Has histologically confirmed locally advanced (Stage IIIB/C) or metastatic (Stage IV) non-squamous NSCLC
• Aged 18-80 years at the time of consent
• Has KRAS G12C mutation confirmed by central laboratory
• Has not received prior systemic therapy for advanced or metastatic NSCLC
• Has at least one measurable lesion per RECIST v1.1
• ECOG performance status of 0-1
• Has adequate organ function
• Life expectancy ≥3 months in the opinion of the Investigator
• Male and female subjects of reproductive potential must agree to use effective contraception during and for 6 months after treatment