Actively Recruiting
Neoadjuvant Chemo-Immunotherapy and Surgical Resection 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
335 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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 consent
- Histologically or cytologically confirmed stage 3B/C non-small cell lung cancer with pathologically confirmed contralateral mediastinal or ipsilateral supraclavicular (N3) lymph node involvement
- Primary tumor suitable for surgical removal with curative intent as assessed by the treating surgeon
- No major health conditions or co-morbidities that make surgery too risky as assessed by the surgeon
- Lung function sufficient to tolerate the planned lung surgery
- EGFR and ALK wild-type status confirmed by certified tissue testing, except not required for pure squamous NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate blood counts and organ function based on recent lab tests within 21 days before starting treatment
- Women of childbearing potential must agree to use effective contraception or abstain from heterosexual intercourse during treatment and for 4 months after
- Men must agree to use contraception or abstain from heterosexual intercourse during treatment and for 4 months after
You will not qualify if you...
- NSCLC with histology of large cell neuroendocrine carcinoma or small cell lung cancer
- Tumor not suitable for surgery due to invasion of mediastinum, diaphragm, heart, great vessels, trachea, esophagus, vertebral body, or carina, or other surgical unsuitability
- Prior systemic therapy for this lung cancer, including chemotherapy or immunotherapy
- History of cancer requiring systemic therapy within 2 years except certain low-risk cases
- Active or significant autoimmune disease that could compromise safety with anti-PD1 therapy, except stable thyroid disease, controlled type 1 diabetes, adrenal insufficiency on stable steroids, or certain controlled skin conditions
- History of serious lung diseases or active pneumonitis
- Active tuberculosis
- Poorly controlled HIV, hepatitis B or C infections, unless controlled and stable
- Severe infection requiring hospitalization within 3 weeks before treatment
- Prior allogeneic stem cell or solid organ transplant
- Treatment with live attenuated vaccine within 4 weeks before treatment or planned during study
- Significant heart or vascular disease within 6 months before treatment
- Use of systemic immunosuppressive medications within 2 weeks before treatment except certain low-dose or stable regimens
- Prior immune checkpoint inhibitor therapy
- History of severe allergic reaction to study drugs
- Pregnancy, breastfeeding, or intention to become pregnant during treatment or within 6 months after
AI-Screening
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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
CONTACT
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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