Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months.

Detailed Description
-----------------
Immunotherapy with anti-PD1 antibody, such as Pembrolizumab, is widely used in the treatment of stage III/IV non small cell lung cancer. In order to refine treatments and patients' prognosis, early assessment of tumour response is needed. The aim of this study is to describe the early tumour metabolic changes in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response. Eligible patients with stage III/IV, PDL1>50% NSCLC will receive pembrolizumab treatment as per standard of care. Tumour metabolism will be assessed by 18-FDG PETscan before each of the 3 first pembrolizumab infusions. Treatment response will be determined by RECIST, irRC and mCHOI criteria at 3 months. Prognostic and predictive value of baseline and dynamic metabolic parameters will be assessed.

Official Title
-----------------
18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Device: PET scan imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non operable non small cell lung cancer Indication of treatment by Pembrolizumab PD-L1 status superior to 50 % Age more than 18 years At least one measurable target Written inform consent Exclusion Criteria: no treatment by pembrolizumab immunosuppressive treatment uncontrolled diabete Pregnancy or breast-feeding curatorship or guardianship not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET scan imaging<br>PET scan will be performed each of three first cycles of pembrolizumab to describe the early tumour metabolic changes during the first line of treatment. | Device: PET scan imaging<br>* 3 PET scans will be performed after each 3 first infusions of Pembrolizumab<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of progression by early PET scan | Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Time between inclusion and progression | 24 months | 
| Overall survival | Time between inclusion and death | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET scan imaging, Pembrolizumab, Response, Parametric imaging