Actively Recruiting
Neoadjuvant Chemo-Immunotherapy and Surgery in Locally Advanced Non-Small Cell Lung Cancer with N3 Lymph Node Involvement
Led by Georgetown University · Updated on 2026-02-12
21
Participants Needed
3
Research Sites
248 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating neoadjuvant cemiplimab combined with histology-specific chemotherapy followed by surgery and adjuvant cemiplimab in patients with stage 3 non-small cell lung cancer (NSCLC) that involves contralateral mediastinal or ipsilateral supraclavicular lymph nodes (N3). This study aims to determine if surgery to remove the cancer is possible after receiving chemotherapy plus immunotherapy. The trial focuses on patients with locally advanced NSCLC and lymph node involvement. Participants receive platinum-doublet chemotherapy along with the immunotherapy drug cemiplimab. The treatment before surgery includes four cycles of this three-drug combination administered every three weeks. After surgery, radiation therapy may be offered if recommended by the treatment team. Following radiation, participants receive cemiplimab every three weeks for one year. This approach combines neoadjuvant (pre-surgery) and adjuvant (post-surgery) therapy to assess its impact. During the study, participants undergo evaluations including surgery to remove the tumor, possible radiation therapy, and ongoing immunotherapy treatments. Researchers measure the pathologic complete response rate at 12 weeks post-treatment, along with other outcomes such as objective response rate at one year, rate of complete tumor removal, major pathologic response, disease-free survival, and overall survival over five years. Participants will be closely monitored with laboratory tests and clinical assessments to evaluate treatment effects and safety throughout the study.
CONDITIONS
Brief Title
Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent.
- Confirmed stage 3B or 3C Non-Small Cell Lung Cancer with contralateral mediastinal or ipsilateral supraclavicular (N3) lymph node involvement.
- Primary tumor suitable for surgical removal with curative intent as assessed by surgeon.
- No major health issues or co-morbidities that make surgery too risky.
- Lung function sufficient to tolerate planned lung surgery.
- EGFR and ALK wild-type status confirmed unless pure squamous NSCLC.
- ECOG Performance Status 0 or 1.
- Adequate blood counts and organ function within 21 days before treatment.
- Women of childbearing potential agree to use effective contraception or abstain during treatment and 4 months after.
- Men agree to use effective contraception or abstain during treatment and 4 months after.
You will not qualify if you...
- NSCLC histology including large cell neuroendocrine carcinoma or small cell lung cancer.
- Tumor not suitable for surgery due to invasion of critical structures or other reasons.
- Any prior systemic therapy for lung cancer including chemotherapy or immunotherapy.
- Recent history of other cancers requiring systemic therapy within 2 years, except low-risk cases.
- Active or significant autoimmune diseases that may be unsafe with PD-1 immunotherapy, except controlled hypothyroidism, diabetes, adrenal insufficiency, or certain skin conditions.
- History of lung diseases such as idiopathic pulmonary fibrosis or pneumonitis.
- Active tuberculosis.
- Poorly controlled HIV, hepatitis B or C infections.
- Severe infection within 3 weeks before treatment start.
- Previous stem cell or organ transplant.
- Recent live vaccine use or planned live vaccine during study.
- Significant heart or vascular disease within 6 months before treatment.
- Recent use of systemic immunosuppressants excluding some exceptions.
- Prior immune checkpoint therapy.
- Severe allergic reactions to study drug components.
- Pregnancy, breastfeeding, or intention to become pregnant during and for 6 months after treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive cemiplimab plus chemotherapy for 4 treatment cycles before surgery, followed by surgical resection.
4 visits every 3 weeks before surgery and 1 surgery visit
Duration - Up to 1 year
After surgery, participants receive cemiplimab every 3 weeks for up to 1 year.
Regular visits every 3 weeks for up to 1 year
Trial Site Locations
Total: 3 locations
1
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Washington University School of Medicine-Sitemen Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
3
UVA Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
J
Joshua Reuss, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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