A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer
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)?
Arms & interventions
- DrugCemiplimab
Intravenous (IV) infusion administration
- DrugPlatinum-based chemotherapy
IV infusion
- DrugREGN7075
IV infusion
Outcome measures
Primary
Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)
Time frame: Up to 12 weeks
Secondary
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
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
Eligibility criteria
Study locations (14)
University of California Irvine
Orange, California, 92868
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
Karmanos Cancer Institute
Detroit, Michigan, 48201
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
Morristown Medical Center
Morristown, New Jersey, 07960
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Providence Portland Medical Center
Portland, Oregon, 97213
University Of Nebraska Medical Center
Portland, Oregon, 97213
Lifespan Cancer Institute
Providence, Rhode Island, 02903
Prairie Lakes Healthcare System
Watertown, South Dakota, 57201
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology
Nashville, Tennessee, 37203
BRCC/Oncology & Hematology Associates of SW Virginia
Blacksburg, Virginia, 24060