Evaluation of low dose immunotherapy for lung cancer
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2023/02/050126
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <= 1.5 mg or creatinine clearance >=50 ml/min.
B. Serum Bilirubin < 1.5 UNL, AST/ALT < 3 UNL
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method