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)?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Intravenous (IV) infusion administration
IV infusion
IV infusion
University of California Irvine
Orange, California, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
Oncology Hematology Care Clinical Trials LLC
Cincinnati, Ohio, United States
Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)
Time frame: Up to 12 weeks
Pathologic complete response (pCR) rate as determined by central BIPR
Time frame: Up to 12 weeks
Residual viable tumor (RVT) as determined by central BIPR
Time frame: Up to 12 weeks
Median event-free survival (EFS)
Time frame: Up to 5 years
EFS rate
Time frame: Up to 5 years
Objective response rate (ORR)
Time frame: Up to 9 weeks
Overall survival (OS)
Time frame: Up to 5 years
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 76 weeks
Severity of TEAEs
Time frame: Up to 76 weeks
Incidence of TEAEs leading to death
Time frame: Up to 76 weeks
Incidence of TEAEs leading to treatment discontinuation
Time frame: Up to 76 weeks
Incidence of serious adverse events (SAEs)
Time frame: Up to 76 weeks
Incidence of adverse events of special interest (AESIs)
Time frame: Up to 76 weeks
Incidence of immune-mediated adverse events (imAEs)
Time frame: Up to 76 weeks
Incidence of infusion-related reactions (IRRs)
Time frame: Up to 76 weeks
Incidence of grade ≥3 laboratory abnormalities
As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)
Time frame: Up to 76 weeks
Proportion of delayed surgeries due to TEAEs
Time frame: Up to 76 weeks
Proportion of cancelled surgeries due to TEAEs
Time frame: Up to 76 weeks
Incidence of anti-drug antibodies (ADAs) to cemiplimab over time
Time frame: Up to 67 weeks
Titer of ADAs to cemiplimab over time
Time frame: Up to 67 weeks
Incidence of ADAs to novel anti-cancer agents over time
Time frame: Up to 67 weeks
Titer of ADAs to novel anti-cancer agents over time
Time frame: Up to 67 weeks
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Providence Portland Medical Center
Portland, Oregon, United States
University Of Nebraska Medical Center
Portland, Oregon, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
...and 37 more locations