Thoracic RadiothErapy With Atezolizumab in Small Cell lUng canceR Extensive Disease

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.

Timeline

Start

2020-07-28

Primary completion

2024-09-02

Completion

2024-09-02

Outcome

Missed primary endpoint

paper Median OS in the combination arm was numerically shorter compared to atezolizumab only (6.7 months [95% CI, 5.1-9.0] vs 13.4 months [95% CI, 10.7-17.5]; HR, 1.55 [95% CI, 0.90-2.69]; P = .34) PMID 42424047 ↗

Publications

• Bozorgmehr F, Chung I, Behnisch R, Weykamp F, Adeberg S, Overbeck T, El Shafie R, Maguire N, Koerber SA, Buchmeier EL, Hammer-Hellmig M, Gauler T, Pottgen C, Wermke M, Troost EGC, Kokowski K, Roper B, Reinacher-Schick A, Consdorf NS, Ulmer M, Muller AC, Wehler T, Hey-Koch S, Alt J, Stockinger M, Kuon J, Bischof M, Lamprecht B, Geinitz H, Lerchenmuller C, Kriz J, Rauter M, Raunik W, Schmidt B, Stupavsky A, Kropf-Sanchen C, Schmidtke-Schrezenmeier G, Wiegel T, Tufman A, Manapov F, Merling M, Heussel CP, Polke M, Reck M, Al-Batran SE, Thomas M, Christopoulos P, Rieken S. Consolidative Thoracic Radiotherapy With Atezolizumab Maintenance in Extensive-Stage Small Cell Lung Cancer: The Phase 2 TREASURE Randomized Clinical Trial (AIO-TRK-0320). JAMA Oncol. 2026 Jul 9. doi: 10.1001/jamaoncol.2026.2330. Online ahead of print.
• Bozorgmehr F, Christopoulos P, Chung I, Cvetkovic J, Feisst M, Krisam J, Schneider MA, Heussel CP, Kreuter M, Muller DW, Thomas M, Rieken S. Protocol of the TREASURE study: Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease - a randomized, open-label, multicenter phase II trial. BMC Cancer. 2022 Sep 24;22(1):1011. doi: 10.1186/s12885-022-10074-9.

Drugs

Indications