CTRI/2023/02/050126
Not yet recruiting
Phase 2
Evaluation of low dose nivolumab with neoadjuvant chemotherapy in non small cell lung cancer - ELo
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Indian Council of Medical Research
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<\= 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)
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.
Outcomes
Primary Outcomes
Not specified
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