Clinical trial of Mycobacterium w in Combination with Paclitaxel and Cisplatin in Advanced non small cell lung cancer patients.

Open label, randomized multicentric clinical trial of Mycobacterium w in combination with Paclitaxel plus Cisplatin versus paclitxel and cisplatin in advanced Non Small Cell Lung Cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2007/091/000037

Enrollment

221

Registered

2009-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Interventions

Intervention1: Mycobacterium W+Cisplation+Paclitaxel: Test arm will receive (Paclitaxel + Cisplatin) by intravenous infusion on day 1 of a 21 days cycle. Mw will be given intradermally 0.2 ml at least

Eligibility

Inclusion criteria

Inclusion criteria: 1.INFORMED CONSENT OBTAINED & SIGNED: o Ability to understand and the willingness to sign a written informed consent document. 2.DISEASE CHARACTERISTICS: o Histologically or cytologically confirmed Non-Small Cell Lung Cancer, Stage IIIB or IV 3.PATIENT CHARACTERISTICS: o Age: -18 completed years and above o Performance status -ECOG 0-1 o Life expectancy -At least 24 weeks o Hematopoietic -Absolute neutrophil count >= 1,500/mm3 -Platelet count >= 1,00,000/mm3 -Hemoglobin >= 9.0 g/dL o Hepatic -AST and ALT -Bilirubin not greater than 1.5 times ULN range of institution (3 times ULN if liver involvement). o Renal - Serum Creatinine less than 1.5 times upper limit of normal (ULN) range of Institutional Lab Range. 4. Negative Pregnancy test for women of child bearing potential prior to entry into the trial.

Exclusion criteria

Exclusion criteria: 1. Patients who have had cytotoxic chemotherapy or radiotherapy prior to entering the study. 2. Patients with symptomatic brain metastasis 3. History of allergic reactions attributed to paclitaxel, cisplatin or mycobacteria or any of their ingredients. 4. Pregnant women or nursing women 5. Uncontrolled intercurrent illness that would limit compliance with study requirements. 6. HIV positive patients 7. Previous splenectomy

Design outcomes

Primary

Measure	Time frame
1. To determine & compare the overall survival time of patients in the two arms. 2. To determine & compare the effect of this treatment on Quality of life in the two arms. Timepoint: After study completion	—

Secondary

Measure	Time frame
1. To determine & compare the Response rate in the two arms. 2. To study & compare the (hematological) toxicity in the two arms. Timepoint: After study completion	—

Countries

India

Contacts

Public ContactDr Bhaumik Mody

Cadila pharmaceuticals ltd.

ashish.akar@cadilapharma.co.in912714221481

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026