NCT01836679

Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

A Phase II Study of Chidamide or Placebo in Combination With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.

Detailed description

The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.

Conditions

• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Chidamide	Given orally
DRUG	Paclitaxel	Given IV
DRUG	Carboplatin	Given IV
DRUG	Placebo	Given orally

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-05-01
• Completion: 2015-12-01
• First posted: 2013-04-22
• Last updated: 2016-02-01

Locations

8 sites across 1 country: China