This study focuses on Non-Small Cell Lung Cancer that is advanced or has spread to other parts of the body (metastatic), specifically in patients who have not received previous treatment and whose cancer has a specific genetic change called KRAS G12C mutation. The study will test a combination of medications including divarasib (also known as GDC-6036) and pembrolizumab (KEYTRUDA) compared to a combination of pembrolizumab with pemetrexed and either carboplatin or cisplatin.
The study aims to determine whether the combination of divarasib and pembrolizumab works better than the standard treatment combination in treating this type of lung cancer. The medications will be given through different routes – divarasib as tablets taken by mouth, while pembrolizumab, pemetrexed, carboplatin, and cisplatin are given through an intravenous infusion (through a vein).
During the study, doctors will monitor how the cancer responds to treatment and track any side effects that may occur. They will also assess how the treatment affects patients’ quality of life and symptoms related to their cancer, such as cough and breathing difficulties. The study will measure how long patients live without their cancer getting worse and their overall survival time.
1Initial assessment
Your eligibility for the study will be confirmed based on specific criteria, including having advanced or metastatic non-squamous non-small cell lung cancer that cannot be treated with surgery.
A test will confirm the presence of a specific genetic mutation called KRAS G12C in your tumor or blood sample.
Your physical condition will be evaluated using the ECOG Performance Status scale, which must be 0 or 1.
2Treatment assignment
You will be randomly assigned to one of two treatment groups:
Group 1: Treatment with divarasib (oral tablets) and pembrolizumab (intravenous infusion)
Group 2: Treatment with pembrolizumab, pemetrexed, and either carboplatin or cisplatin (all given as intravenous infusions)
3Treatment period
Your treatment will be given in cycles
Regular assessments will monitor your response to treatment using imaging scans
Blood tests and physical examinations will be conducted to monitor your health
You will complete quality of life questionnaires about your symptoms and daily functioning
4Monitoring period
Your health status will be regularly monitored through physical examinations
Side effects will be tracked using standardized criteria
The effectiveness of the treatment will be measured by tracking how your disease responds
Quality of life assessments will continue throughout the study
5Study completion
The study is expected to continue until December 2030
Your participation duration will depend on how your disease responds to treatment and any side effects you may experience
Who Can Join the Study?
Must have non-squamous non-small cell lung cancer (a type of lung cancer) that is advanced or has spread to other parts of the body, and has not been previously treated
Must have a KRAS G12C mutation (a specific genetic change) confirmed through testing of tumor tissue or blood sample
Must have cancer that can be measured using standard imaging methods (RECIST v1.1 criteria)
Must have good physical function, with an ECOG Performance Status of 0 or 1 (ability to perform daily activities with minimal assistance)
Must have a life expectancy of at least 12 weeks
Must have cancer that cannot be cured with surgery or radiation therapy combined with chemotherapy
Must not have received any previous systemic treatment (medication that travels through the bloodstream) for advanced lung cancer
Both men and women may participate in the study
Must be an adult (18 years or older)
Who Cannot Join the Study?
Prior treatment with systemic therapy for advanced or metastatic non-small cell lung cancer
Known active brain metastases (cancer that has spread to the brain) or spinal cord compression
History of other cancer within 3 years before starting the study, except for adequately treated non-melanoma skin cancer or carcinoma in situ
Active autoimmune disease requiring systemic treatment within the past 2 years (a condition where the immune system attacks healthy cells)
History of severe allergic reactions to monoclonal antibodies (a type of targeted therapy)
Active infection requiring systemic therapy
Uncontrolled heart conditions including heart failure, irregular heartbeat, or high blood pressure
History of pneumonitis (inflammation of lung tissue) requiring steroids
Active hepatitis B or C infection
Known history of HIV infection
Receipt of live vaccine within 30 days prior to starting treatment
Pregnant or breastfeeding women
Any condition that would interfere with the safety of the participant or the quality of the study data
Divarasib is a targeted therapy medication designed to treat specific types of lung cancer that have a particular genetic mutation called KRAS G12C. It works by blocking the abnormal protein that causes cancer cells to grow and spread.
Pembrolizumab is an immunotherapy medication that helps the body’s immune system recognize and fight cancer cells. It works by blocking a protein that prevents immune cells from attacking cancer cells, allowing the immune system to work more effectively against the cancer.
Pemetrexed is a chemotherapy medication that works by stopping cancer cells from making DNA and other molecules they need to grow and multiply. It is commonly used to treat non-small cell lung cancer.
Carboplatin is a platinum-based chemotherapy medication that works by damaging the DNA of cancer cells, which prevents them from dividing and causes them to die. It is widely used to treat various types of cancer.
Cisplatin is another platinum-based chemotherapy medication that, like carboplatin, works by damaging cancer cell DNA. It is also commonly used in the treatment of various cancers, including lung cancer.
Non-Small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the large cells of the lung, specifically in non-squamous cells. It typically develops slowly and forms in the tissues of the lung, particularly in cells that line the air passages. Non-squamous NSCLC includes adenocarcinoma and large cell carcinoma subtypes. When described as advanced or metastatic, it means the cancer has spread beyond its original location to other parts of the body. This condition often develops without early symptoms, becoming noticeable only in later stages when the tumor has grown larger.
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