Survival Prolongation by Rationale Innovative Genomics

Phase 1/2 Terminated 15 enrolled Worldwide Innovative Network Association ARC Foundation for Cancer Research · collab Pfizer · collab

NaSingle-groupOpen-labelTreatment

Summary

Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.

Timeline

Start: 2017-11-29
Primary completion: 2022-12-29
Completion: 2022-12-29

Outcome

Outcome not reported

Stopped (Business): “The SPRING trial had to be early terminated at the end of the Phase 1 portion of the study due to the absence of funding necessary for the performance of the Phase 2.”

Publications

Solomon B, Callejo A, Bar J, Berchem G, Bazhenova L, Saintigny P, Wunder F, Raynaud J, Girard N, Lee JJ, Sulaiman R, Prouse B, Bresson C, Ventura H, Magidi S, Rubin E, Young B, Onn A, Leyland-Jones B, Schilsky RL, Lazar V, Felip E, Kurzrock R. A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer. Cancer Med. 2022 Jul;11(14):2790-2800. doi: 10.1002/cam4.4635. Epub 2022 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Axitinib	Small molecule	3 mg	Oral
Subject	Palbociclib	Small molecule	75 mg	Oral