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

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Trial Identification

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

Official Title: 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)

Study ID: NCT02564380

Conditions

Metastatic Squamous Non-small Cell Lung Cancer

Interventions

Pembrolizumab

Placebo

Study Description

Brief 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.