Efficacy Study of Vx001 Vaccine in NSCLC Patients

Summary

Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stable disease) within 3 weeks after platinum based 1st line chemotherapy; only HLA-A\*0201 positive patients with TERT expressing tumors will be included. The objective of the trial is survival rate at 12 months.

Timeline

Start

2012-08

Primary completion

2017-01

Completion

2017-01

Outcome

Missed primary endpoint

paper The study did not meet its primary endpoint PMID 32210365 ↗

paper median OS 11.3 and 14.3 months for the placebo and the Vx-001, respectively; p = 0.86 PMID 32210365 ↗

Publications

• Gridelli C, Ciuleanu T, Domine M, Szczesna A, Bover I, Cobo M, Kentepozidis N, Zarogoulidis K, Kalofonos C, Kazarnowisz A, Korozan M, de Las Penas R, Majem M, Chella A, Griesinger F, Bournakis E, Sadjadian P, Kotsakis A, Chinet T, Syrigos KN, Correale P, Gallou C, Jamet JM, Vetsika EK, Kosmatopoulos K, Georgoulias V; Vx-001-201 trial team. Clinical activity of a htert (vx-001) cancer vaccine as post-chemotherapy maintenance immunotherapy in patients with stage IV non-small cell lung cancer: final results of a randomised phase 2 clinical trial. Br J Cancer. 2020 May;122(10):1461-1466. doi: 10.1038/s41416-020-0785-y. Epub 2020 Mar 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vx-001	Vaccine	—	—

Indications