Expanded Access Program for Divarasib in Patients with Advanced KRAS G12C-Positive Non-Small Cell Lung Cancer

Inclusion Criteria

• Have advanced or metastatic non-small cell lung cancer that cannot be treated with surgery or combined chemotherapy and radiation.
• Cancer must have worsened during or after at least one previous standard treatment, but no more than three different treatments.
• Must have a confirmed KRAS G12C mutation in the cancer.
• Be in relatively good health with an ECOG performance status of 0 to 2.
• Have a life expectancy of at least 12 weeks.
• Be able to swallow tablets whole.

Exclusion Criteria

• Have previously participated in a study of divarasib by Roche or Genentech.
• Have been treated with a pan-KRAS/RAS inhibitor before.
• Have been treated with a KRAS G12C inhibitor unless specific conditions are met.
• Be pregnant, breastfeeding, or planning to become pregnant during the program.
• Have an allergy to any part of divarasib.
• Have a condition that affects the absorption of medications in the stomach or intestines.
• Have mixed small-cell lung cancer.
• Have untreated or active cancer spread to the brain or spinal cord.
• Have cancer spread to the membranes around the brain or spinal cord.
• Have uncontrolled fluid buildup around the lungs, heart, or abdomen that needs frequent drainage.
• Have significant liver disease or a history of liver disease, including hepatitis or cirrhosis.
• Have a positive HIV test.
• Have had a major injury or surgery within the last four weeks.
• Have chronic diarrhea or significant gastrointestinal issues.
• Have received cancer treatment within the last 28 days.
• Have had more than 30 Gy of radiation to the lungs in the last six months.
• Have uncontrolled pain from tumors.
• Have unresolved side effects from previous cancer treatments.
• Are taking certain medications that affect liver enzymes within 14 days before starting the program.
• Have any serious medical condition that would make participation unsafe.
• Have had a blood or platelet transfusion within the last 14 days.
• Have a significant heart condition or abnormal ECG.
• Have another active cancer that is being treated or not well controlled.
• Have significant heart disease within the last six months.
• Have a history of heart rhythm problems or risk factors for them.