study to compare effectiveness and safety of two regimes in advanced stage non small cell lung cancer.
Phase 3
Completed
- Conditions
- Health Condition 1: null- ADVANCED STAGE NON SQUAMOUS NON SMALL CELL LUNG CANCERHealth Condition 2: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2016/12/007605
- Lead Sponsor
- All INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion Criteria
Age 18-65 years
• Tissue diagnosis of Non-squamous Non-small cell lung cancer
• Stage IIIB (not amenable for radical CTRT) and stage IV
• Performance status ECOG 0, 1 and 2
• Normal renal and hepatic functions
â?? Creatinine clearance >50ml/min
â?? SGOT and SGPT < 2.5times of
Exclusion Criteria
• Patients who have received prior chemotherapy
• Already known EGFR/ALK mutation, if being considered for TKI
• Symptomatic brain metastasis (Asymptomatic brain metastasis and stabilized brain
metastasis after WBRT would be considered)
• Immunosuppression (HIV, or other immunosuppressant medication)
• Symptomatic neuropathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare Progression Free Survival in both armsTimepoint: AFTER FOUR CYLES OF INDUCTION CHEMOTHERAPY
- Secondary Outcome Measures
Name Time Method 1.To compare overall response rate in both arms <br/ ><br>2. To compare toxicity profile in both arms <br/ ><br>3. To compare Overall Survival in both arms <br/ ><br>4. To compare disease control rate (CR/PR/SD) between the two induction treatment arms <br/ ><br>5. To assess role of TS level and FRA level as predictive biomarkerTimepoint: AT THE END OF THE INDUCTION CHEMOTHERAPY