Conditions: NSCLC
Keywords: Vandetanib, NSCLC, Maintenance, Phase II
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 117
Healthy volunteers: no

Brief summary:
This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Vandetanib intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, oral, daily intervention 2: Placebo

Protocol document: