Non Small Cell Lung Cancer
Conditions
Keywords
PET scan imaging, Pembrolizumab, Response, Parametric imaging
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.
Interventions
DEVICEPET scan imaging
3 PET scans will be performed after each 3 first infusions of Pembrolizumab
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of progression by early PET scan | 3 months | Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 24 months | Time between inclusion and progression |
| Overall survival | 24 months | Time between inclusion and death |
Countries
France
Outcome results
None listed