Nintedanib Compared With Placebo in Treating Against Radiation-Induced Pneumonitis in Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery and Are Undergoing Chemoradiation Therapy

Phase 2 Terminated 8 enrolled Roswell Park Cancer Institute National Cancer Institute (NCI) · collab

RandomizedParallel-groupDouble-blindSupportive care

Summary

This trial studies the side effects and how well nintedanib works compared to a placebo in treating against radiation-induced pneumonitis (inflammation of the lungs) in patients with non-small cell lung cancer that cannot be removed by surgery and are undergoing chemoradiation therapy. Nintedanib may help shrink or slow the growth of radiation-induced pneumonitis by blocking some of the enzymes needed for cells to grow and may prevent the growth of new blood vessels. It may also help reduce the recurrence of non-small cell lung cancer.

Timeline

Start: 2015-06-29
Primary completion: 2019-06-10
Completion: 2019-06-10

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Enrollment): “low accrual”

registry analysis (superiority test); Arm I (Nintedanib) vs Arm II (Placebo); p = 0.107; Cochran-Mantel-Haenszel NCT02452463 ↗

Publications

Rimner A, Moore ZR, Lobaugh S, Geyer A, Gelblum DY, Abdulnour RE, Shepherd AF, Shaverdian N, Wu AJ, Cuaron J, Chaft JE, Zauderer MG, Eng J, Riely GJ, Rudin CM, Els NV, Chawla M, McCune M, Li H, Jones DR, Sopka DM, Simone CB 2nd, Mak R, Weinhouse GL, Liao Z, Gomez DR, Zhang Z, Paik PK. Randomized Phase 2 Placebo-Controlled Trial of Nintedanib for the Treatment of Radiation Pneumonitis. Int J Radiat Oncol Biol Phys. 2023 Aug 1;116(5):1091-1099. doi: 10.1016/j.ijrobp.2023.02.030. Epub 2023 Mar 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nintedanib	Small molecule	—	Oral
Background	Durvalumab	Monoclonal antibody	—	Intravenous