A Randomized Phase II/III Study of Docetaxel and Ramuciru...

Primary Objective:
1.1. Primary Objectives

To compare overall survival (OS) between participants randomized to docetaxel and ramucirumab with or without cemiplimab (REGN2810) who have acquired resistance to platinum-based chemotherapy and immunotherapy for Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

Secondary Objectives:

To compare investigator-assessed progression-free survival (PFS) per RECIST 1.1 between the arms.
To compare investigator-assessed response rates (confirmed or unconfirmed, complete response (CR) or partial response (PR)) per RECIST 1.1 between the arms among participants with measurable disease.
To compare the investigator-assessed disease control rate (confirmed or unconfirmed, complete response (CR), or partial response (PR), and stable disease) between the arms.
To evaluate the duration of response (DoR) among responders within each arm.
To evaluate the frequency and severity of toxicities within each arm.
To compare investigator-assessed PFS between the arms within the subgroups defined by the stratification factors (histology and performance status) and by PD-L1 subgroups defined as PD-L1 negative (<1% TPS), intermediate PD-L1 (1-49% TPS), and PD-L1 high (>=50% TPS).
To compare OS between the arms within the subgroups defined by the stratification factors (histology and performance status) and by PD-L1 subgroups defined as PD-L1 negative (<1% TPS), intermediate PD-L1 (1-49% TPS), and PD-L1 high (>=50% TPS).

Exploratory Objectives:

To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at baseline, cycle 3 day 1, and progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA).
NOTE: The proposal to use these specimens would be submitted as an amendment to CTEP for approval prior to SDMC reviewing the results.
To establish a tissue/blood repository to pursue future studies.

Clinical Trial Details