Study on Sotorasib for People with Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Must provide written consent to participate.
• Have a confirmed diagnosis of metastatic or recurrent non-small cell lung cancer.
• Have a KRAS G12C mutation identified through previous tumor biopsy or blood test.
• Have not received any prior treatment for advanced cancer.
• Have measurable disease according to specific medical criteria.
• Have a performance status score of 70% or higher, indicating the ability to carry out daily activities.
• Be 18 years or older.
• Have adequate organ function, including:
  • Hemoglobin levels of at least 10 g/dL.
  • Platelet count of at least 75,000 per microliter.
  • Neutrophil count greater than 1.5 x 10^9/L.
  • Liver enzymes and bilirubin within specified limits.
  • Kidney function within specified limits.
• Be willing to undergo tumor biopsies before and during treatment.
• Decline or have progressed after previous chemotherapy or immunotherapy for early-stage NSCLC.
• Women must not be able to become pregnant or must use effective birth control methods.
• Men must use condoms and ensure their partners use effective birth control methods.

Exclusion Criteria

• Have symptomatic brain metastases.
• Have received radiation therapy or major surgery within one week of starting the study treatment.
• Have received certain cancer therapies within 12 weeks of starting sotorasib.
• Have unresolved side effects from previous treatments.
• Have a history of severe lung inflammation from previous treatments.
• Have severe heart failure or recent hospitalization for heart failure.
• Have gastrointestinal issues that prevent taking oral medication.
• Have active hepatitis B or C infections.
• Have other active or chronic liver diseases.
• Are participating in another clinical trial or have recently completed one.
• Are using certain medications that affect liver enzymes or drug absorption without approval from the study team.
• Are unable or unwilling to undergo required tumor biopsies.