Conditions: Non-Small Cell Lung Cancer
Keywords: Locally Advanced Metastatic Non-Squamous Non-Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the overall survival of patients receiving E7080 + Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.

Detailed description:
This double-blind, placebo-controlled, multicenter, randomized Phase II study will consist of a 2-arm design, comparing E7080 + BSC (Arm 1) with placebo + BSC (Arm 2). Participants will be randomized in the ratio of 2:1 to receive either E7080 or placebo in a blinded manner.

Arms:
arm 1: Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle plus Best Supportive Care (BSC) arm 2: Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle plus BSC

Interventions: intervention 1: Lenvatinib intervention 2: Lenvatinib matched placebo intervention 3: BSC
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: