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CTRI Number  CTRI/2024/02/063096 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 09/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Correlation of PET CT reesponse and post surgery and chemotherapy biopsy response in lung cancer patients 
Scientific Title of Study   Metabolic response by FDG PET-CT and its correlation with pathological response and genomic profile in patients of Non-Small Cell Lung Cancer (NSCLC) receiving neoadjuvant chemoimmunotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aparna Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 110 Academic Block National Cancer Institute Village Badsa Jhajjar District All India Institute of Medical sciences- Delhi


HARYANA
124105
India 
Phone  7895683095  
Fax    
Email  aparna96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aparna Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 110 Academic Block National Cancer Institute Village Badsa Jhajjar District All India Institute of Medical sciences- Delhi


HARYANA
124105
India 
Phone  7895683095  
Fax    
Email  aparna96@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aparna Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 110 Academic Block National Cancer Institute Village Badsa Jhajjar District All India Institute of Medical sciences- Delhi


HARYANA
124105
India 
Phone  7895683095  
Fax    
Email  aparna96@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  All India Institute of Medical Sciences Ansari Nagar New Delhi-110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aparna Sharma  AIIMS New Delhi  Room no 110 Academic Block National Cancer Institute Village Badsa Jhajjar District All India Institute of Medical sciences- Delhi
Jhajjar
HARYANA 		 7895683095

aparna96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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)
 
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of PERCIST based response on FDG PET-CT vis a vis RECIST based Response by CECT and their correlation with pathological responses.
 		 At Baseline and post completion of Neoadjuvant chemotherapy (9-12 weeks)
 
 
Secondary Outcome  
Outcome  TimePoints 
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.  Baseline and after 3 cycles NACT 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aparna96@gmail.com].

  6. For how long will this data be available start date provided 02-06-2026 and end date provided 02-06-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Neoadjuvant chemoimmunotherapy and response to therapy is an active area of research in Non- Small Cell Lung Cancers (NSCLC). However, there is wide heterogeneity amongst regimens used and their responses as determined at pathology after surgery. In low and middle-income countries, immunotherapy in any setting is still largely inaccessible due to cost issues.

Response assessment to neoadjuvant therapy is conventionally done by contrast enhanced computed tomography (CECT) as per Response Evaluation Criteria In Solid Tumors (RECIST criteria). However, these criteria have certain limitations. Fluoride-18 (18F)-fluorodeoxyglucose (FDG) positron emission tomography-computed tomography (PET–CT) has been postulated to overcome the fallacies of CECT and has been hypothesized to better predict the response post- surgery after receipt of neoadjuvant therapy. Assessment of metabolic response using PET-CT scan could be useful but definitive criteria remain to be established. These issues are not applicable in the metastatic cohort, as pathologic response is never an endpoint in this setting. Also, in metastatic setting, often differentiation between true response or progression and pseudoprogression is a challenge. Published data however for this setting are sparse and have not been explored in the Indian population.

Through this feasibility pilot study, we plan to test our hypothesis that, whether a PET-CT done prior to surgery would be better able to predict the pathological responses to chemoimmunotherapy. Also, as an exploratory endpoint we plan to explore the radiogenomic aspect in the Indian cohort. By doing genomic profiling in the baseline tissue sample, we plan to assess whether there exists a distinctive genomic signature of patients who respond versus non responders to chemo-immunotherapy. The data of this genomic signature in Indian population is lacking.

Hence, with the recent evidence of benefit and approval of neoadjuvant therapy, this study may provide a unique opportunity to assess whether metabolic response as well as baseline genomic profile serves as a predictor and/or is prognostic of postoperative response in patients with resectable lung cancers.

 
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