Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Emory Vaccine Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female at age 18-75 years. 2. Confirmed pathological diagnosis of NSCLC. 3. Eastern Co-operative Oncology Group (ECOG) performance status 0-2. 4. After multidisciplinary tumor board discussion, being considered for: 4a. Upfront surgical resection (stage 1-3A disease) 4b. Neoadjuvant chemotherapy followed by surgical resection (mostly stage 3 A disease) 4c. Neoadjuvant immunotherapy followed by surgical resection (mostly stage 3 A disease) 4d. Stage 4 (metastatic) disease being considered for first line immunotherapy based on PD-L1 TPS (Tumor proportion score) >=50%. 5.Willing to continue treatment and follow up at any of the participating clinical sites (TMC or AIIMS)
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Congenital or acquired immunodeficiency disorders. 3. Active autoimmune disorders requiring >10 mg of prednisone or dose equivalent. Hypothyroidism requiring only hormone replacement would be allowed. 4. Patients with untreated or symptomatic brain metastasis. 5. Hepatitis B or C infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine if expansion of T cell populations in blood predicts response to anti-PD1 therapy 2. To understand the immune response in lung tunours and understand if these parameters correlate with subsequent response to anti-PD1 therapy.Timepoint: 2 weeks after first dose After 3 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| To create an inter-disciplinary team of clinicans and researchers with complementary and synergistic expertise. Establish the joint EVC-TMC program for research excellence in immuno-ocology in India.Timepoint: 5 years | — |
Countries
India
Contacts
Public ContactDr C S Pramesh
Tata Memorial Hospital
Outcome results
None listed