Comparing Divarasib with Pemetrexed for non-small cell lung cancer

Inclusion

• +Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors
• +History of leptomeningeal disease
• +Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• +Measurable disease, as defined by RECIST v1.1
• +No prior systemic treatment for advanced or metastatic NSCLC
• +Documentation of the presence of a KRAS G12C mutation
• +Documentation of known PD-L1 expression status in tumor tissue
• +Availability of a representative tumor specimen
• +Adequate end-organ function
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → Related to NSCLC:
• +Known concomitant second oncogenic driver with available targeted treatment
• +Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• +Uncontrolled tumor-related pain
• +Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
• +Exclusion Criteria Related to Current or Prior Treatments:
• +Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, or is expected to require any other form of antineoplastic therapy while in the study
• +Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors
• +Current treatment with medications that are well known to prolong the QT interval
• +Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization
• +Prior allogeneic stem cell or solid organ transplantation
• +Exclusion Criteria Related to General Health:
• +History of malignancy other than NSCLC within 5 years prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \[OS\] rate \>90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
• +History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan
• +Significant cardiovascular disease within 3 months prior to screening
• +Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy
• +Eligible to receive a platinum-based chemotherapy regimen
• +Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to randomization
• +Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung \>30Gy within 6 months prior to randomization
• +Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption