NCT02580994

Pembrolizumab in Untreated Extensive SCLC

REACTION: A Phase II Study of Etoposide and Cis/Carboplatin With or Without Pembrolizumab in Untreated Extensive Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, two armed, controlled, and randomized phase II trial investigating the activity of pembrolizumab in combination with standard chemotherapy in Extensive Disease (ED)-SCLC.

Detailed description

This is a multicenter, open-label, two armed, controlled, and randomized phase II trial investigating the activity of pembrolizumab in combination with standard chemotherapy in ED-SCLC. Extended stage Small Cell Lung Cancer (SCLC) patients will be registered, after signing the informed consent, and then centrally randomized 1:1 to the experimental arm (Arm A) and the control arm (Arm B). Cross-over at the time of disease progression will be allowed for arm B only.

Conditions

• Small Cell Lung Cancer (SCLC)

Interventions

Type	Name	Description
DRUG	Pembrolizumab	IV infusion at the dose of 200 mg on day 1 every 3 weeks
DRUG	cis/carboplatin and etoposide	Cisplatin 80 mg/m2 or Carboplatin Area Under the Curve (AUC) 5 IV infusion on day 1 Etoposide 100 mg/m2 IV infusion on day 1, 2 and 3

Timeline

• Start date: 2017-12-08
• Primary completion: 2020-09-22
• Completion: 2022-06-22
• First posted: 2015-10-20
• Last updated: 2023-12-11

Locations

18 sites across 3 countries: France, Italy, United Kingdom