cemiplimab
DrugIntravenous (IV) infusion administration
Other names: REGN2810, LIBTAYO
NCT Number: NCT06465329
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)?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Oncology Clinical Research Center, Cachoeiro de Itapemirim, Espírito Santo, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
General Key Inclusion Criteria:
General Key Exclusion Criteria:
Arm Specific Exclusion Criteria:
Arm 1:
Note: Other protocol-defined Inclusion/Exclusion criteria apply.
Intravenous (IV) infusion administration
Other names: REGN2810, LIBTAYO
IV infusion
IV infusion
Other names: EGFRxCD28 bispecific immunotherapy
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: Up to 12 weeks
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: Up to 9 weeks
Time frame: Up to 5 years
Time frame: Up to 76 weeks
Time frame: Up to 76 weeks
Time frame: Up to 76 weeks
Time frame: Up to 76 weeks
Time frame: Up to 76 weeks
Time frame: Up to 76 weeks
Time frame: Up to 76 weeks
Time frame: Up to 76 weeks
Time frame: Up to 76 weeks
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
Time frame: Up to 76 weeks
Time frame: Up to 67 weeks
Time frame: Up to 67 weeks
Time frame: Up to 67 weeks
Time frame: Up to 67 weeks
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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