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Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC

NCT06623656 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Cemiplimab

Intravenously

DRUG

Platinum based chemotherapy

Intravenously

RADIATION

Stereotactic body radiation therapy

8 Gy times 3 treatment days (Days 1-3)

Sponsors & Collaborators

Principal Investigators

  • Nasser K Altorki, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2026-12-31
Completion
2032-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623656 on ClinicalTrials.gov