Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: NIL: NIL
Control Intervention1: NIL: NIL
Control Intervention2: NIL: NIL
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Age 18-75 years Pathological diagnosis of NSCLC in Stage 2B or 3A . Being considered for neoadjuvant chemotherapy followed by surgery after discussion in MDT. Complete surgical removal should be deemed achievable including surgical fitness. ECOG (Eastern Cooperative Oncology Group) performance score 0to1. Adequate organ functions and marrow functions as described below A. Serum creatinine less than equal to 1.5 mg or creatinine clearance more than equal 50 ml/min. B. Serum Bilirubin less than 1.5 UNL, ASTor ALT less than 3 UNL C. Hb more than 10.0 gmdl, Platelet counts more than 100 x10 9 L, absolute neutrophil count more than 1.5 X10 9L Able to understand the PIS (patient information sheet and give informed consent)
Exclusion criteria
Exclusion criteria: ECOG performance score more or equal to 2 .Harboring EGFR mutations, ALK and ROS1 rearrangements.Prior exposure to immune checkpoint inhibitors. Pre-existing autoimmune condition requiring systemic immunosuppression including steroids (more than 10 mg Prednisolone equivalent). Acquired immunosuppression (HIV, systemic immunosuppression) .Hematopoietic or organ transplant recipient. History of any other malignancy in past or synchronous malignancy.Pregnant and lactating mothers. Willing to afford or have access to immunotherapy outside study.Patients with any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or compromise the patient’s ability to participate in this study.Uncontrolled diabetes mellitus with fasting plasma glucose persistently above 200 mgdl which could compromise the patient’s ability to undergo FDG PET-CT scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of PERCIST based response on FDG PET-CT vis a vis RECIST based Response by CECT and their correlation with pathological responses. Timepoint: At Baseline and post completion of Neoadjuvant chemotherapy (9-12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of PERCIST criteria in patients receiving chemotherapy alone with its immunotherapy adapted iterations viz. imPERCIST and iPERCIST in patients receiving chemoimmunotherapy to predict pathological response.Timepoint: Baseline and after 3 cycles NACT | — |
Countries
India
Contacts
Public ContactAparna Sharma
All India Institute of Medical Sciences
Outcome results
None listed