drugset / Trial / NCT05800015

A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer

NCT05800015

Phase 2/3 Active not recruiting 160 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each study drug is in your blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) * How administering the study drugs might improve your quality of life

Timeline

Start
2023-08-08
Primary completion
2030-01-16
Completion
2031-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Fianlimab Monoclonal antibody Intravenous
Background Carboplatin Small molecule Intravenous
Background Cemiplimab Monoclonal antibody Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Paclitaxel Small molecule Intravenous
Background Pemetrexed Small molecule Intravenous