Clinical trial · Interventional
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.
NCT00680940CI-TRIAL-00007744NSCLCcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mycobacterium w. | Biological | — | UNRESOLVED |
| Paclitaxel & Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- Paclitaxel + Cisplatin
- interventionNames
- Drug: Paclitaxel & Cisplatin
- type
- EXPERIMENTAL
- label
- Chemoimmunotherapy
- description
- Paclitaxel + Cisplatin + Mycobacterium w
- interventionNames
- Biological: Mycobacterium w.
Primary outcomes (1)
- measure
- Overall survival time of patients, quality of life
- timeFrame
- 12 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.