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Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC

NCT02591615 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2022-12-28

Study results available
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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.

Conditions

Interventions

DRUG

MK-3475

Dose frequency of Q3W, Day 1 of each cycle

DRUG

Carboplatin

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

DRUG

Paclitaxel

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

DRUG

Pemetrexed

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

Sponsors & Collaborators

Principal Investigators

  • Monica Bertagnolli, MD · Alliance Foundation Trials, LLC.

  • Thomas Hensing, MD · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-01-04
Completion
2020-07-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591615 on ClinicalTrials.gov