To successfully develop novel ways of identifying Indian patients that are likely to benefit from immunotherapy for lung cancer
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2022/05/042559
- Lead Sponsor
- Emory Vaccine Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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)
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method