Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Gemcitabine-Cisplatin in Early Stages NSCLC

NCT00191126 ↗

Phase 3 Completed 263 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

Preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (NSCLC) .The use of preoperative Cisplatin/Gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the Phase II setting. The aim of the present Phase III study is to determine whether 3 cycles of preoperative chemotherapy with Cisplatin/Gemcitabine improves progression free survival of NSCLC patients versus surgery alone. Postoperative chemotherapy will not be utilized in this Phase III trial.

Timeline

Start: 2000-09
Primary completion: 2007-09
Completion: 2007-09

Outcome

Met primary endpoint

paper The hazard ratios for PFS and overall survival were 0.70 (95% CI, 0.50 to 0.97; P = .003) PMID 22124104 ↗

paper both in favor of chemotherapy plus surgery. PMID 22124104 ↗

Publications

Results Scagliotti GV, Pastorino U, Vansteenkiste JF, Spaggiari L, Facciolo F, Orlowski TM, Maiorino L, Hetzel M, Leschinger M, Visseren-Grul C, Torri V. Randomized phase III study of surgery alone or surgery plus preoperative cisplatin and gemcitabine in stages IB to IIIA non-small-cell lung cancer. J Clin Oncol. 2012 Jan 10;30(2):172-8. doi: 10.1200/JCO.2010.33.7089. Epub 2011 Nov 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1250 mg/m2	Intravenous