Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Chemotherapy: For squamous carcinoma- paclitaxel 175 mg/m2 with carboplatin AUC-5 backbone will be used for 4 cycles delivered 21 days apart. While for adenocarcinoma pemetrexed 500 mg/
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients willing to comply with the protocol and have signed IEC or IRB approved informed consent form (ICF). 2 Histologically confirmed Stage IIIb/IV NSCLC patients (as per AJCC Classification) without any driver mutation planned with treatment with palliativecare 3 Eligible for cytotoxic combination chemotherapy as a first linetherapy 4 Male or female patient aged 18-years or more; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and Life Expectancy of at least 24weeks 5 Adequate organ function as evidenced by hematological and biochemical tests. 6 Negative pregnancy test for women of child bearing potential prior to entry into the trial. Women of childbearing potential or men with partners of childbearing potential must use effective physical contraceptive measures during treatment and at least 6 months after the last dose of the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
Exclusion criteria
Exclusion criteria: 1 Patients with untreated symptomatic brain metastasis. Patients with symptomatic brain mets after receiving RT to brain can be included in the study 2 Malignancy other than NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or carcinoma insitu of the cervix. 3 History of allergic reactions attributed to paclitaxel, platinum based chemotherapy or mycobacteria or any of their ingredients 4 Pregnant women or nursingwomen 5 Uncontrolled inter- current illness that would limit compliance with study requirements 6 HIV positive patients with CD4 count less than 200 7 Previous splenectomy 8 A major surgical procedure, or significant traumatic injury 9 Current, recent, or planned participation in another experimental drug study 10 Patients who had cytotoxic chemotherapy and/or radiotherapy (except palliative radiotherapy within 2 weeks prior to enrollment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall SurvivalTimepoint: Randomization till death | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To compare safety 2 To assess Tumour responserate 3 To compare PFS 4 To compare EORTC QOL Timepoint: 1 At every visit till Progression 2 Every 2 months till Progression 3 till disease progression 4 every visit | — |
Countries
India
Contacts
Public ContactDr Kumar Prabhash
Tata Memorial Hospital
Outcome results
None listed