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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Paclitaxel & Cisplatin
* Biological: Mycobacterium w.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemotherapy<br>Paclitaxel + Cisplatin | Drug: Paclitaxel & Cisplatin<br>* Chemotherapeutic agent<br>|
| Experimental: Chemoimmunotherapy<br>Paclitaxel + Cisplatin + Mycobacterium w | Biological: Mycobacterium w.<br>* Immunomodulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival time of patients, quality of life |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, Hematological toxicity |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC