Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: chemoimmunotherapy: 1. Injection Nivolumab 40 mg (flat dose) IV infusion over 30 minutes every 3 weeks (day 1 of every cycle) plus
2. Injection Paclitaxel 80 mg/m2 IV infusion over 1 hr
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years 2. Pathological diagnosis of NSCLC 3. Stage 2B or 3A disease 4. Being considered for neoadjuvant chemotherapy followed by surgery after discussion in MDT (Multi-disciplinary tumour board). Complete surgical removal should be deemed achievable including surgical fitness. 5. ECOG PS 0-1. 6. Adequate organ functions and marrow functions as described below A. Serum creatinine =50 ml/min. B. Serum Bilirubin C. Hb >10.0 gm/dl, Platelet counts >100 X109 /L, absolute neutrophil count > 1.5 X109/L 7. Able to understand the PIS (patient information sheet and give informed consent)
Exclusion criteria
Exclusion criteria: 1. ECOG PS >=2 2. Harbouring EGFR mutations, ALK and ROS1 rearrangements 3. Prior exposure to immune checkpoint inhibitors. 4. Pre-existing autoimmune condition requiring systemic immunosuppression including steroids ( >10 mg Prednisolone equivalent). 5. Acquired immunosuppression (HIV, systemic immunosuppression) 6. Haematopoietic or organ transplant recipient. 7. History of any other malignancy in past or synchronous malignancy 8. Pregnant and lactating mothers 9. Willing to afford or have access to immunotherapy outside study 10. Patients with any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or compromise the patientâ??s ability to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response ratesTimepoint: At the time of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points: 1. Radiological response rates 2. Safety evaluation Timepoint: During and after neoadjuvant treatment | — |
Countries
India
Contacts
Public ContactDr Prabhat Singh Malik
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
Outcome results
None listed