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
Regeneron Pharmaceuticals
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)?
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCemiplimab
Intravenous (IV) infusion administration
- DrugPlatinum-based chemotherapy
IV infusion
- DrugREGN7075
IV infusion
Locations (49)
- University of California IrvineOrange, California
- Orchard Healthcare Research Inc.Skokie, Illinois
- Karmanos Cancer InstituteDetroit, Michigan
- Detroit Clinical Research CenterFarmington Hills, Michigan
- Morristown Medical CenterMorristown, New Jersey
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey