Phase II Iressa Versus Vinorelbine (INVITE)

Phase 2 Completed 192 enrolled AstraZeneca

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.

Timeline

Start: 2004-07
Primary completion: —
Completion: 2006-02

Outcome

Missed primary endpoint

paper Hazard ratios (HR; gefitinib v vinorelbine) were 1.19 (95% CI, 0.85 to 1.65) for PFS PMID 18779612 ↗

paper There was no statistical difference between gefitinib and vinorelbine in efficacy in chemotherapy-naïve, unselected elderly patients with advanced NSCLC PMID 18779612 ↗

Publications

Crino L, Cappuzzo F, Zatloukal P, Reck M, Pesek M, Thompson JC, Ford HE, Hirsch FR, Varella-Garcia M, Ghiorghiu S, Duffield EL, Armour AA, Speake G, Cullen M. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol. 2008 Sep 10;26(26):4253-60. doi: 10.1200/JCO.2007.15.0672.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefitinib	Small molecule	250 mg	Oral
Subject	Vinorelbine	Small molecule	30 mg/m2	—