drugset / Trial / NCT02591615

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

NCT02591615 ↗

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 6 unknown Intravenous
Comparator Paclitaxel Small molecule 200 mg/m2 Intravenous
Comparator Pembrolizumab Monoclonal antibody 200 mg/m2 Intravenous
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous