NCT03379441

Pembrolizumab (MK-3475) as Maintainance in Treated Patients With Unresectable Stage III NSCLC

A Randomized Phase II Study of Pembrolizumab (MK-3475) as Maintainance Therapy in Patients With Unresectable Stage III Non-small Cell Lung Cancer Treated With Definitive Chemo-radiotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Maintainance therapy in patients with unresectable stage III, NSCLC Stage IIIA-B, unresectable, NSCLC, treated with definitive Chemo-Radiotherapy

Detailed description

This is an Italian multi-center randomized phase II trial (randomization 2:1) of intravenous (IV) MK-3475 (Pembrolizumab) versus observation as a maintenance therapy after chemo-radiotherapy (either concomitant or sequential, regardless of the type of chemotherapy used) in unresectable stage IIIA-IIIB non small cell lung cancer (NSCLC) patients.

Conditions

• Non Small Cell Lung Cancer Patients

Interventions

Type	Name	Description
DRUG	Pembrolizumab Injectable Product	Pembrolizumab Injectable Product 200 mg Q3W Intravenous

Timeline

• Start date: 2018-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2017-12-20
• Last updated: 2017-12-22

Locations

14 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study