CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
MK-3475 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02591615
NCT02591615Phase 2Completed

Randomized Phase II Trial Evaluating the Optimal Sequencing of PD-1 Inhibition With Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in Patients With Chemotherapy Naive Stage IV Non-small Cell Lung Cancer

Alliance Foundation Trials, LLC.·interventional·Posted Oct 29, 2015·Updated Dec 28, 2022

In Brief

A Phase 2 clinical trial evaluating MK-3475, Carboplatin, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 91 participants across 11 sites.

Detailed Summary

This is a multicenter randomized phase II to determine if the administration of standard platinum-based chemotherapy before MK-3475 in with Chemotherapy naive stage IV Non-small Cell Lung Cancer (NSCLC) will improve the overall response rate (ORR) compared to MK-3475 administered before chemotherapy. Patients will be given Pembrolizumab as maintenance up to 2 years: Carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab every 3 weeks for up to 2 years. Pembrolizumab every 3 weeks x 4 cycles followed by carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab every 3 weeks for up to 2 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 29, 2015
Enrollment StartMar 1, 2016
Primary CompletionJan 4, 2019
Study CompletionJul 4, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.7 years ago

Interventions

MK-3475drug

Dose frequency of Q3W, Day 1 of each cycle

Carboplatindrug

Dose frequency of Q3W, Day 1 of each cycle (standard Chemotherapy)

Paclitaxeldrug

Dose frequency of Q3W, Day 1 of each cycle (standard Chemotherapy)

Pemetrexeddrug

Dose frequency of Q3W, Day 1 of each cycle (standard Chemotherapy)