Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced NSCLC

Phase 3 Terminated 20 enrolled RTOG Foundation, Inc. Bristol-Myers Squibb · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Patients with Stage III unresectable non-small cell lung cancer will receive thoracic radiation, cisplatin and etoposide followed by nivolumab or placebo given every 2 weeks for a year.

Timeline

Start: 2016-10-17
Primary completion: 2019-01-23
Completion: 2019-01-23

Outcome

Outcome not reported

Stopped: “Another treatment found efficacious”

Publications

Gerber DE, Urbanic JJ, Langer C, Hu C, Chang IF, Lu B, Movsas B, Jeraj R, Curran WJ, Bradley JD. Treatment Design and Rationale for a Randomized Trial of Cisplatin and Etoposide Plus Thoracic Radiotherapy Followed by Nivolumab or Placebo for Locally Advanced Non-Small-Cell Lung Cancer (RTOG 3505). Clin Lung Cancer. 2017 May;18(3):333-339. doi: 10.1016/j.cllc.2016.10.009. Epub 2016 Oct 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Background	Cisplatin	Other / unclassified	50 mg/m2	Intravenous
Background	Etoposide	Small molecule	40 mg/m2	Intravenous