Study Comparing Divarasib and Pembrolizumab with Standard Chemotherapy for Advanced KRAS G12C-Mutated Lung Cancer

Inclusion Criteria

• Must be in good general health, able to carry out all normal activities or only slightly restricted (ECOG performance status 0 or 1).
• Have a confirmed diagnosis of advanced or metastatic non-squamous NSCLC that cannot be treated with surgery or radiation to cure it.
• Have at least one tumor that can be measured by scans.
• Have not received any previous treatment for advanced or metastatic NSCLC.
• Have a confirmed presence of the KRAS G12C mutation in the cancer.
• Have known PD-L1 expression status in the tumor.
• Must provide a sample of the tumor for testing.
• Have good organ function as shown by medical tests.
• Be eligible to receive chemotherapy that includes platinum-based drugs.

Exclusion Criteria

• Have another known genetic mutation in the cancer that can be treated with targeted therapy.
• Have untreated or worsening cancer spread to the brain or spinal cord.
• Have spinal cord compression that has not been treated or is not stable.
• Have a history of cancer spread to the membranes around the brain and spinal cord.
• Have uncontrolled pain from the tumor.
• Have fluid buildup around the lungs, heart, or abdomen that needs frequent drainage.
• Have received any cancer treatment, including hormone therapy, within 21 days before starting the study.
• Have had radiation therapy to the bones within 2 weeks or to the lungs within 6 months before starting the study.
• Have been treated with KRAS G12C inhibitors or similar drugs before.
• Are taking medications that affect the immune system or prolong the QT interval on an ECG.
• Have taken antibiotics by mouth or IV within 2 weeks before starting the study.
• Have had a stem cell or organ transplant.
• Have had another cancer within the last 5 years, except for certain low-risk cancers.
• Have chronic digestive issues or surgeries that affect nutrient absorption.
• Have a history of lung diseases like pulmonary fibrosis or pneumonia.
• Have had significant heart disease within 3 months before starting the study.