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NCT06096844 · ClinicalTrials.gov record · last posted 2026-08-27

Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

StatusRecruiting
PhasePhase 3
Started2024-07-19
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from the ClinicalTrials.gov record
This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV 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 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. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

Protocol amendment history 3 changes detected by DataLookout

2026-07-21
Trial sites expanded: 319 → 322 locations
2026-05-15
Primary completion pushed: 2026-06-01 → 2035-01-31
2026-05-15
Completion pushed: 2026-06-01 → 2035-01-31
Trial Details
NCT Number NCT06096844
Lead Sponsor National Cancer Institute (NCI)
Conditions Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
Enrollment 304 participants
Start Date 2024-07-19
Primary Completion 2035-01-31 (estimated)
Study Completion 2035-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-27