Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment (iTEP1)
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|ClinicalTrials.gov Identifier: NCT03832348|
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Device: PET scan imaging||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||February 5, 2019|
|Estimated Primary Completion Date :||March 17, 2020|
|Estimated Study Completion Date :||December 17, 2021|
Experimental: PET scan imaging
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
3 PET scans will be performed after each 3 first infusions of Pembrolizumab
- Determination of progression by early PET scan [ Time Frame: 3 months ]Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab
- Progression free survival [ Time Frame: 24 months ]Time between inclusion and progression
- Overall survival [ Time Frame: 24 months ]Time between inclusion and death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832348
|Contact: Stephanie Becker, MDfirstname.lastname@example.org|
|Contact: Doriane Richard, PhDemail@example.com|
|Centre Henri Becquerel||Not yet recruiting|
|Rouen, France, 76000|
|Contact: Stephanie Becker, MD|
|CHU||Not yet recruiting|
|Rouen, France, 76000|
|Contact: Luc Thiberville, Md, PhD|
|Principal Investigator:||Stephanie Becker, MD||Centre Henri Becquerel|
|Principal Investigator:||Florian Guisier, MD||CHU Rouen|