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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT06449313
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Non-small Cell Lung Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab-Rwlc — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2032

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab plus chemotherapy
    cemiplimab given with standard of care chemotherapy for 4 treatments/cycles before surgery and then every 3 weeks for 1 year after surgery.

Primary Outcome Measure

Pathologic complete response (pCR) rate [ Time Frame: 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer Center, Georgetown UniversityWashington D.C.District of Columbia20007
Jenny Crawford, RN
[email protected]
202-687-0893
Joshua Reuss, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine-Sitemen Cancer CenterSt LouisMissouri63110
Medical Oncology Clinical Call Center
[email protected]
314-747-1171
Ece Cali Daylan, MD, PhD (PRINCIPAL_INVESTIGATOR)
UVA Comprehensive Cancer CenterCharlottesvilleVirginia22908
Yaro Shvorak, CCRC
[email protected]
434-297-7384
Ryan Gentzler, MD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
Lombardi Comprehensive Cancer Center, Georgetown University· Washington D.C., DCWashington University School of Medicine-Sitemen Cancer Center· St Louis, MOUVA Comprehensive Cancer Center· Charlottesville, VA

Related Studies