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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 21, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT03793179). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8. Interventions: PROCEDURE: Biospecimen Collection; DRUG: Carboplatin; PROCEDURE: Computed Tomography; PROCEDURE: Magnetic Resonance Imaging; BIOLOGICAL: Pembrolizumab; DRUG: Pemetrexed; PROCEDURE: Positron Emission Tomography. Primary outcome measures: Overall survival (OS) , From randomization to death from any cause, assessed up to 5 years post treatment. Brief summary: This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.