NCT00680940

A Study of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin in Advanced Non Small Cell Lung Cancer

Open Label, Randomized Multicentric Phase II Clinical Trial of Mycobacterium w in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel and Cisplatin in Advanced Non Small Cell Lung Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Cadila Pharnmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Mycobacterium w in combination with Paclitaxel plus Cisplatin are effective in Advanced Non Small Cell Lung cancer.

Detailed description

Non-small cell lung cancer (NSCLC) accounts for 75% of all lung cancers. majority of patients of NSCLC patients are stage IIIA or IIIB patients are suitable for radiotherapy, which could not improve the survival rates of 5-10%. This study proposed Mycobacterium w (heat killed) in combination chemotherapy of Cisplatin and Paclitaxel along with radiotherapy for adjuvant therapy management of NSCLC in controlled clinical trial, which may prove the efficacy, better survival rate and quality of life.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel & Cisplatin	Chemotherapeutic agent
BIOLOGICAL	Mycobacterium w.	Immunomodulator

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-05-20
• Last updated: 2012-08-07

Locations

14 sites across 1 country: India