NCT06449313

Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement

A Phase 2 Single-Arm Study of Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advance Non-Small Cell Lung Cancer (NSCLC) With N3 Lymph Node Involvement

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. 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.

Conditions

• Non-small Cell Lung Cancer Stage III

Interventions

Type	Name	Description
DRUG	Cemiplimab-Rwlc	350 mg every 3 weeks, intravenously, on day 1 of a 21 day cycle for 4 cycles, then every 3 weeks after surgery for 1 year.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2032-09-01
• First posted: 2024-06-10
• Last updated: 2026-02-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study