Spots Global Cancer Trial Database for Study of Motesanib (AMG 706) in Combination With Paclitaxel and Carboplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: Study of Motesanib (AMG 706) in Combination With Paclitaxel and Carboplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer

Official Title: A Global Phase 3, Randomized, Placebo Controlled, Double-Blind Trial of AMG 706 in Combination With Paclitaxel and Carboplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer (Asian Phase 3 Study)

Study ID: NCT02629848

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Study Description

Brief Summary: This study will evaluate progression free survival (PFS), overall survival (OS), objective response rate (ORR), duration of response, and safety of motesanib (AMG706) in combination with paclitaxel and carboplatin compared to placebo in combination with paclitaxel and carboplatin.

Detailed Description: The drug being tested in this study is called motesanib. Motesanib is being tested in combination with paclitaxel and carboplatin to treat people who have Stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). This study will look at progression free survival, overall survival, overall response and safety. The study enrolled 401 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Motesanib 125 mg + Paclitaxel + Carboplatin * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient + Paclitaxel + Carboplatin All participants were asked to take 5 X 25 mg motesanib tablets or placebo at the same time each day throughout the study. All participants received treatment with paclitaxel 200 mg/m\^2 intravenous (IV) and carboplatin IV on Day 1 of each 3 week Cycle for up to 6 Cycles. After 6 Cycles participants could continue to receive motesanib or placebo alone for up to 36 months. This multi-centre trial was conducted worldwide. The overall time to participate in this study was up to 36 months. Participants made multiple visits to the clinic, plus a final visit 30 days after receiving their last dose of study drug for a follow-up assessment.