Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 6, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT06449313). This is a study registration, not published results. Lead sponsor: Georgetown University. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 21 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer Stage III. Interventions: DRUG: Cemiplimab-Rwlc. Primary outcome measures: Pathologic complete response (pCR) rate , 12 weeks. Brief summary: The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with select N3 lymph node involvement or other high-risk subsets in which there is no consensus on resectability. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year.