Status:

RECRUITING

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

Lead Sponsor:

Regeneron Pharmaceuticals

Conditions:

Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned. The aim is to find out whether an investigational treatment (consist...

Eligibility Criteria

General Key Inclusion Criteria:

  1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
  2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
  3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
  4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
  5. Adequate organ and bone marrow function, as described in the protocol

General Key Exclusion Criteria:

  1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
  2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol
  3. Presence of grade≥ 2 peripheral neuropathy
  4. Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Arm 1:

  1. Grade ≥3 hypercalcemia, as defined in the protocol
  2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
  3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion criteria apply.

Key Trial Info

Start Date :

November 18 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 2 2030

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06465329

Start Date

November 18 2024

End Date

May 2 2030

Last Update

February 12 2026

Active Locations (49)

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Page 1 of 13 (49 locations)

1

University of California Irvine

Orange, California, United States, 92868

2

Orchard Healthcare Research Inc.

Skokie, Illinois, United States, 60077

3

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

4

Detroit Clinical Research Center

Farmington Hills, Michigan, United States, 48334

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) | DecenTrialz