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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of PERCIST based response on FDG PET-CT vis a vis RECIST based Response by CECT and their correlation with pathological responses.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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 0to
- •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.
- •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).
排除标准
- •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).
- •â€¨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.
结局指标
主要结局
Evaluation of PERCIST based response on FDG PET-CT vis a vis RECIST based Response by CECT and their correlation with pathological responses.
时间窗: At Baseline and post completion of Neoadjuvant chemotherapy (9-12 weeks)
次要结局
- 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)
研究者
Aparna Sharma
All India Institute of Medical Sciences