Fostering Efficacy of Anti - PD-1 - Treatment: Nivolumab Plus Radiotherapy in Advanced NSCLC

Summary

AIO-YMO/TRK-0415 (FORCE) is a Phase 2, open-label of nivolumab, patients with metastatic non-squamous NSCLC with the necessity of radiotherapy of a metastatic site (e.g. bone) in 2nd-line or 3rd-line treatment for study group A and patients with metastatic non-squamous NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment for study Group B.

Timeline

Start

2017-02-10

Primary completion

2020-12-31

Completion

2020-12-31

Outcome

Missed primary endpoint

paper With an objective response rate (ORR) of 8.3% in group A (n = 41), the primary endpoint was not met (p = 0.991). PMID 40702361 ↗

Publications

• Bozorgmehr F, Chung I, Fischer JR, Bischof M, Atmaca A, Wetzel S, Faehling M, Bottke D, Wermke M, Troost EGC, Kropf-Sanchen C, Wiegel T, Schmidt B, Stupavsky A, Engel-Riedel W, Hammer-Hellmig M, Reinmuth N, Manapov F, Grohe C, Krempien R, Schumann C, Sterzing F, Reck M, Wurschmidt F, Fleckenstein J, Petroff A, Henschke S, Behnisch R, Cvetkovic J, Bruckner L, Schwab C, Stenzinger A, Gotze T, Kopp C, Schroder H, Debus J, Christopoulos P, Thomas M, Rieken S. Reconsidering palliative radiotherapy in addition to PD-1 blockade for non-small cell lung cancer: results from the FORCE phase II trial (AIO/YMO-TRK-0415). Clin Exp Metastasis. 2025 Jul 24;42(5):42. doi: 10.1007/s10585-025-10358-x.
• Bozorgmehr F, Hommertgen A, Krisam J, Lasitschka F, Kuon J, Maenz M, Huber PE, Konig L, Kieser M, Debus J, Thomas M, Rieken S. Fostering efficacy of anti-PD-1-treatment: Nivolumab plus radiotherapy in advanced non-small cell lung cancer - study protocol of the FORCE trial. BMC Cancer. 2019 Nov 8;19(1):1074. doi: 10.1186/s12885-019-6205-0.

Drugs

Indications