Study of Participants With Advanced Non-Small Cell Lung Cancer

Phase 3 Completed 361 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.

Timeline

Start: 2009-09-01
Primary completion: 2013-01-31
Completion: 2020-11-06

Outcome

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

registry p = 0.176; Log Rank NCT00948675 ↗

paper Pem+Cb did not produce significantly better G4PFS compared with Pac+Cb+Bev. PMID 25371077 ↗

Publications

Zinner RG, Obasaju CK, Spigel DR, Weaver RW, Beck JT, Waterhouse DM, Modiano MR, Hrinczenko B, Nikolinakos PG, Liu J, Koustenis AG, Winfree KB, Melemed SA, Guba SC, Ortuzar WI, Desaiah D, Treat JA, Govindan R, Ross HJ. PRONOUNCE: randomized, open-label, phase III study of first-line pemetrexed + carboplatin followed by maintenance pemetrexed versus paclitaxel + carboplatin + bevacizumab followed by maintenance bevacizumab in patients ith advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Jan;10(1):134-42. doi: 10.1097/JTO.0000000000000366.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	15 mg/kg	Intravenous
Subject	Carboplatin	Small molecule	6 unknown	Intravenous
Comparator	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous