Study on the Safety and Effects of Divarasib with Other Cancer Treatments for Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation
Sponsor: Hoffmann-La Roche
Sponsor score: 40
ClinicalTrials ID:NCT05789082
This clinical trial is testing a new treatment called divarasib, combined with other cancer therapies, to see if it is safe and effective for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has not been treated before.
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Program Overview
The aim of this study is to determine if a new treatment, divarasib, when used with other cancer therapies, is safe and effective for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has not been treated previously. Researchers will also study how the body processes the drug.
Eligibility Criteria
Inclusion Criteria
- Must have a specific genetic marker (biomarker) related to the cancer.
- Must provide a tumor sample and pathology report before starting the study. Ideally, the sample should be in a specific format, but exceptions can be made after consulting with the study sponsor.
- Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have advanced or metastatic NSCLC that cannot be treated with surgery or standard chemotherapy and radiation.
- Must not have received any previous treatment for advanced or metastatic NSCLC.
- Must have measurable cancer that can be tracked using standard criteria.
Exclusion Criteria
- Have another cancer with a known treatment available.
- Have a type of lung cancer called squamous cell NSCLC.
- Have untreated or worsening cancer that has spread to the brain or spinal cord.
- Have previously been treated with a KRAS G12C inhibitor.
- Have allergies to any components of the study drugs or related medications.
- Have a history of certain lung diseases or active lung infections.
- Have had another type of cancer within the last five years, except for certain low-risk cancers.
- Have uncontrolled pain or fluid buildup related to the tumor, or high calcium levels in the blood.
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