Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06623656
Phase
PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Intravenously
  • Platinum based chemotherapy — DRUG
    Intravenously
  • Stereotactic body radiation therapy — RADIATION
    8 Gy times 3 treatment days (Days 1-3)

Study Details

The goal of this clinical trial is to learn if Cemiplimab with chemotherapy or Cemiplimab with stereotactic body radiation therapy (SBRT) works as treatment for stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC). Before surgery to remove their lung cancer, participants will take: 1. Cemiplimab with chemotherapy (Arm A) every 3 weeks for up to 3 doses, OR 2. Cemiplimab every 3 weeks for up to 3 doses with SBRT (Arm B). SBRT will be given on day 1 before taking cemiplimab, then SBRT alone on day 2 and day 3. Four to 12 weeks following surgery, participants in both Arm A and Arm B will receive treatment with cemiplimab for one year.

Key Dates

Start date
Feb 21, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2032

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab with chemotherapy (Arm A)
    Before lung cancer surgery: 1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles. 2. Platinum-based chemotherapy intravenously every 3 weeks up to 3 cycles. After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments).
  • Experimental: Cemiplimab with SBRT (Arm B)
    Before lung cancer surgery: 1. Cemiplimab 350 mg intravenously every 3 weeks up to 3 cycles. 2. SBRT on days 1, 2, and 3. After lung cancer surgery, cemiplimab 350 mg intravenously every 3 weeks for 4 treatments followed by 700 mg every 6 weeks for one year (11 treatments).

Primary Outcome Measure

Number of participants with pathological complete response (pCR) [ Time Frame: Surgical resection (Weeks 9-13). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Julissa Murillo
[email protected]
2127463328
Julia Muuse
[email protected]
2127464528
Nasser Altorki, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Weill Cornell Medicine· New York, NY

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