CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
MK-3475 +1 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/NCT02574598
NCT02574598Phase 2Completed
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A Randomized Crossover, Phase II Clinical Trial of MK-3475 in Combination With Docetaxel Versus Docetaxel Alone in Patients With Non-Small Cell Lung Cancer (NSCLC) Previously Treated.

Instituto Nacional de Cancerologia de Mexico·interventional·Posted Oct 14, 2015·Updated Jan 6, 2021

In Brief

A Phase 2 clinical trial evaluating MK-3475 and Docetaxel for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 78 participants across 1 site.

Detailed Summary

This is a phase II open-label randomized clinical trial of MK-3475 (Pembrolizumab) on previously treated non-small cell lung cancer (NSCLC) patients . This drug has shown to allow partial response according to the immune-related response criteria and the response evaluation criteria in solid tumors (RECIST). The main endpoint is to compare the overall response rate (ORR) of MK-3475 with docetaxel or docetaxel alone in patients with advanced NSCLC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesMexico
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 14, 2015
Enrollment StartJun 1, 2016
Primary CompletionOct 1, 2019
Study CompletionNov 19, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.7 years ago

Interventions

MK-3475drug

The dosing interval of pembrolizumab can be increased in case of toxicity.

Docetaxeldrug

Use on both arms as standard of care.