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)
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Berkheim, David
Contact Information:
Kimberly Shields
kimberly.shields@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06465329?term=NCT06465329&rank=1#participation-criteria
Summary
Primary
To evaluate the anti-tumor activity of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy for the perioperative treatment of resectable NSCLC.
Secondary
To evaluate the safety profile of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.
To evaluate the feasibility of surgery in participants receiving cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.
To evaluate the immunogenicity of cemiplimab and novel anticancer agents in the investigational arms, and to evaluate the immunogenicity of cemiplimab in the control arm.
To evaluate the efficacy of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.
Exploratory
To evaluate the efficacy of chemotherapy plus cemiplimab plus novel cancer treatments, and of chemotherapy plus
cemiplimab, separately in participants with tumors that have been tested for oncogenic alterations in EGFR and ALK and lack such alterations.
To evaluate biomarkers that may correlate with mechanism of action and/or therapeutic activity of the treatment regimens using tumor tissue and blood specimens collected from study participants.