Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment (iTEP1)

  • STATUS
    Recruiting
  • End date
    Dec 17, 2023
  • participants needed
    40
  • sponsor
    Centre Henri Becquerel
Updated on 19 February 2022
pembrolizumab
lung carcinoma

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.

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.

Details
Condition Non Small Cell Lung Cancer
Treatment PET scan imaging
Clinical Study IdentifierNCT03832348
SponsorCentre Henri Becquerel
Last Modified on19 February 2022

Eligibility

Yes No Not Sure

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
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