NCT02564380

Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC).

Detailed description

Patients with squamous non-small cell lung cancer and an ECOG of 0-1 who received a first-line therapy with Cis-/Carboplatin for at least 2 cycles that had at least Complete Response (CR) / Partial Response (PR) / Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 will be randomized either to Arm A Pembrolizumab or to Arm B Placebo for a maximum of 2 years or until progressive disease or unacceptable toxicity. The aim is to investigate the efficacy of Pembrolizumab vs. placebo in terms of progression-free survival in patients with metastatic squamous, non-small cell lung cancer. Furthermore to evaluate tumor response, survival, tolerability and safety as well as quality of life of patients receiving Pembrolizumab.

Conditions

• Metastatic Squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab
DRUG	Placebo

Timeline

• Start date: 2016-01-19
• Primary completion: 2020-05-23
• Completion: 2020-11-23
• First posted: 2015-09-30
• Last updated: 2022-01-04

Locations

1 site across 1 country: Germany