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)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06465329
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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 (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.
The study is also looking at several other research questions, including:
* What are the side effects associated with the investigational treatments in comparison to the control treatment?
* Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed?
* How much of the study drug(s) are in the blood at a given time?
* Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy+Cemiplimab Platinum-based chemotherapy Control treatment Arm 1: Chemotherapy+Cemiplimab+REGN7075 Cemiplimab Investigational Treatment Arm 1: Chemotherapy+Cemiplimab+REGN7075 Platinum-based chemotherapy Investigational Treatment Arm 1: Chemotherapy+Cemiplimab+REGN7075 REGN7075 Investigational Treatment Chemotherapy+Cemiplimab Cemiplimab Control treatment
- Primary Outcome Measures
Name Time Method Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR) Up to 12 weeks
- Secondary Outcome Measures
Name Time Method Pathologic complete response (pCR) rate as determined by central BIPR Up to 12 weeks Residual viable tumor (RVT) as determined by central BIPR Up to 12 weeks Median event-free survival (EFS) Up to 5 years EFS rate Up to 5 years Objective response rate (ORR) Up to 9 weeks Overall survival (OS) Up to 5 years Incidence of treatment-emergent adverse events (TEAEs) Up to 76 weeks Severity of TEAEs Up to 76 weeks Incidence of TEAEs leading to death Up to 76 weeks Incidence of TEAEs leading to treatment discontinuation Up to 76 weeks Incidence of serious adverse events (SAEs) Up to 76 weeks Incidence of adverse events of special interest (AESIs) Up to 76 weeks Incidence of immune-mediated adverse events (imAEs) Up to 76 weeks Incidence of infusion-related reactions (IRRs) Up to 76 weeks Incidence of grade ≥3 laboratory abnormalities Up to 76 weeks As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)
Proportion of delayed surgeries due to TEAEs Up to 76 weeks Proportion of cancelled surgeries due to TEAEs Up to 76 weeks Incidence of anti-drug antibodies (ADAs) to cemiplimab over time Up to 67 weeks Titer of ADAs to cemiplimab over time Up to 67 weeks Incidence of ADAs to novel anti-cancer agents over time Up to 67 weeks Titer of ADAs to novel anti-cancer agents over time Up to 67 weeks
Trial Locations
- Locations (31)
Florya Medical Park Hospital
🇹🇷Istanbul, Turkey
University of California Irvine
🇺🇸Orange, California, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
Prairie Lakes Healthcare System
🇺🇸Watertown, Massachusetts, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Detroit Clinical Research Center
🇺🇸Farmington Hills, Michigan, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Lifespan Cancer Institute
🇺🇸Providence, Rhode Island, United States
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