NCT04462276

Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease

Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease: a Randomized, Open-label, Multicenter Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter phase 2 clinical trial to investigate the treatment efficacy and feasibility of combining thoracic radiotherapy (TRT) with the IMpower133 regimen in the upfront treatment of ED SCLC patients. Patients with a response after induction therapy with carboplatin/etoposide and atezolizumab will be included into this study to subsequently receive atezolizumab maintenance therapy and will be randomized to receive TRT or not. This trial aims to i.) increase the efficacy of combined atezolizumab- and chemotherapy by adding radiotherapy and ii.) determine the safety and tolerability of the combination of chemotherapeutic, immunological and radiological treatment in the first-line setting of advanced SCLC, and iii.) to collect tumor tissue as well as blood and stool samples for separate biomarker research project.

Conditions

• Small Cell Lung Cancer Extensive Stage
• Thoracic Radiotherapy

Interventions

Type	Name	Description
DRUG	Atezolizumab	fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W)
RADIATION	thoracic radiotherapy (TRT)	30 Gy in 10 fractions

Timeline

• Start date: 2020-07-28
• Primary completion: 2024-09-02
• Completion: 2024-09-02
• First posted: 2020-07-08
• Last updated: 2025-01-30

Locations

20 sites across 2 countries: Austria, Germany