Loading clinical trials...

RECRUITINGPHASE2

Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC

Multicenter Randomized Phase II Trial of Neoadjuvant Radioimmunotherapy Versus Chemoimmunotherapy in Patients With Clinical Stages IB-III (N2) Non-small Cell Lung Cancer

NCT06623656•Weill Medical College of Cornell University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with histologically or cytologically proven clinical stages IB (T2aN0), II, and III(N2) NSCLC (according to AJCC version 9) eligible for surgical resection with curative intent. Patients with 2 synchronous NSCLC are allowed.
•2. Measurable disease, as defined by RECIST v1.1.
•3. Known PD-L1 expression.
•4. No known EGFR mutations or ALK fusions.
•5. Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.
•6. Age \> 18 years at time of study entry.
•7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•8. No prior therapy for lung cancer
•9. Adequate organ and bone marrow function as defined below:
•* Absolute neutrophil count (ANC) ≥1.5 x10(3)/uL
+13 more criteria

Exclusion Criteria

•1. History of another primary malignancy except for:
•* Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of the study drug and of low potential risk for recurrence.
•* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
•* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ, in-situ urinary bladder cancer, treated localized prostate cancer, and ductal carcinoma in-situ.
•* Indolent hematological malignancies
•2. Current or prior use of immunosuppressive medication within 14 days before the first dose of cemiplimab, with the exceptions of intranasal, inhaled, topical steroids, or local steroid injections (e.g.intra articular injection), corticosteroids or systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid, and steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
•3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]. No active diverticulitis within the previous 3 months. The following are exceptions to this criterion:
•* Patients with vitiligo or alopecia
•* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
•* Any chronic skin condition that does not require systemic therapy
+17 more criteria

Locations (1)

Weill Cornell Medicine

New York, New York, United States

Key Dates

Start Date

February 21, 2025

Primary Completion Date

December 1, 2026

Completion Date

January 1, 2032

Last Updated

October 23, 2025

Enrollment

112

ESTIMATED participants

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cemiplimab

DRUG

Platinum based chemotherapy

DRUG

Stereotactic body radiation therapy

RADIATION

Contacts

Julissa Murillo

CONTACT

2127463328 jum4020@med.cornell.edu

Julia Muuse

CONTACT

212-746-4528 jum4029@med.cornell.edu

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

View study

RECRUITINGPHASE2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC

Inclusion Criteria

Exclusion Criteria

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

A Study of LY4175408 in Participants With Advanced Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)