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:
- Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
- Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
- Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
- Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
- Adequate organ and bone marrow function, as described in the protocol
General Key Exclusion Criteria:
- Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
- 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
- Presence of grade≥ 2 peripheral neuropathy
- Another malignancy that is progressing or requires active treatment, as described in the protocol
Arm Specific Exclusion Criteria:
Arm 1:
- Grade ≥3 hypercalcemia, as defined in the protocol
- Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
- 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)
Enter a location and click search to find clinical trials sorted by distance.
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