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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00680940

Acronym

NSCLC

Enrollment

221

Registered

2008-05-20

Start date

2008-06-30

Completion date

2010-12-31

Last updated

2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC

Brief 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.

Interventions

DRUGPaclitaxel & Cisplatin

Chemotherapeutic agent

BIOLOGICALMycobacterium w.

Immunomodulator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Ability to understand and the willingness to sign a written informed consent document. * Histologically or cytologically confirmed Non-Small Cell Cancer, Stage IIIB or IV. * Age should be 18 years or above. * ECOG should be in 0-1 range. * Absolute neutrophil count ≥ 1,00,000/mm3 * hemoglobin ≥ 9.0g/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN)range of institution (5times ULN if liver metastasis present). * bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver involvement). * Creatinine ≤ upper limit of normal (ULN) range of institution. * Negative pregnancy test for women of child bearing potential prior to entry into the trial.

Exclusion criteria

* Patient who have cytotoxic chemotherapy or radiotherapy prior to entering the study * Patient with systematic brain metastasis. * History of allergic reaction attributed to paclitaxel, cisplatin or mycobacterium w or any of their ingredients. * Pregnant women or nursing women. * Uncontrolled intercurrent illness that would limit compliance with study requirements. * HIV positive patients. * Previous splenectomy.

Design outcomes

Primary

Measure	Time frame
Overall survival time of patients, quality of life	12 months

Secondary

Measure	Time frame
Response rate, Hematological toxicity	12 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026