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A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Non-Small Cell Lung Cancer

Conditions

Lung

Trial Phase

Phase II-III

Trial Purpose and Description

Trial Purpose

Primary: -To compare the overall survival (OS) of previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel. -To compare progression-free survival (PFS) per RECIST 1.1 by independent radiologists¿ review of previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel. -Evaluate safety and tolerability profile of MK-3475 in previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum. Secondary: -To evaluate OS of previously-treated subjects with NSCLC whose tumors express PD-L1 and are treated with MK-3475 compared to docetaxel. -To evaluate PFS per RECIST 1.1 by independent radiologists¿ review of previously-treated subjects with NSCLC whose tumors express PD-L1 and are treated with MK-3475 compared to docetaxel. - To evaluate overall response rate (ORR) per RECIST 1.1 by independent radiologists¿ review in previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel. -To evaluate PFS per immune-related response criteria (irRC) by investigators¿ review in previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel. -To evaluate ORR per irRC by investigators¿ review in previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel. -To evaluate response duration per RECIST 1.1 by independent radiologists¿ review and per irRC by investigators¿ review of previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel. -To evaluate ORR per RECIST 1.1 by independent radiologists¿ review in previously-treated subjects with NSCLC whose tumors express PD-L1 and are treated with MK-3475 compared to docetaxel. Exploratory: -To evaluate the influence of age of tumor specimen (archival vs. new) submitted for PD-L1 analysis on the primary endpoints of progression-free survival and overall survival. -To evaluate tumor volumetric changes of previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel. -To explore the correlation of tumor volumetric changes with OS in previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum with MK-3475 compared to docetaxel. -To evaluate changes in health-related quality-of-life assessments from baseline in previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel using the EORTC QLQ C-30 and EORTC QLQ LC-13. -To characterize utilities in previously-treated subjects with NSCLC in the strongly positive PD-L1 stratum treated with MK-3475 compared to docetaxel using the EuroQoL EQ-5D. -Characterize healthcare resource utilization in previously-treated subjects with NSCLC


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Sponsor:
Merck Sharp & Dohme
Dates:
11/27/2013
Last Updated:
Study HIC#:
1307012448