NCT02591615

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Alliance Foundation Trials, LLC. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

While a genotype-directed strategy has been established as effective in treatment selection for patients with advanced NSCLC, only a minority of patients at this time will have a readily identifiable actionable molecular target. Furthermore, genotype-directed therapy has not been validated for patients with squamous cell carcinoma of the lung. Therefore, the majority of patients with advanced NSCLC will continue to rely on standard platinum-based doublet chemotherapy. Given the plateau in effectiveness of this approach, novel treatment strategies are clearly warranted.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-01-04
• Completion: 2020-07-04
• First posted: 2015-10-29
• Last updated: 2022-12-28
• Results posted: 2022-12-28

Locations

11 sites across 1 country: United States