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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 : Recruiting
First Posted : February 6, 2019
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE February 6, 2019
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date March 17, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2019)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • Progression free survival [ Time Frame: 24 months ]
    Time between inclusion and progression
  • Overall survival [ Time Frame: 24 months ]
    Time between inclusion and death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment
Official Title  ICMJE 18-FDG Tumour Metabolism Changes in PDL1 Superior to 50% Stage III/IV Non Small Cell Lung Cancer During First Line Treatment With Pembrolizumab
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE Device: PET scan imaging
3 PET scans will be performed after each 3 first infusions of Pembrolizumab
Study Arms  ICMJE 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.
Intervention: Device: PET scan imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2019)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 17, 2023
Estimated Primary Completion Date March 17, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephanie Becker, MD +33232888247 stephanie.becker@chb.unicancer.fr
Contact: Doriane Richard, PhD +33232082985 doriane.richard@chb.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03832348
Other Study ID Numbers  ICMJE CHB18.05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre Henri Becquerel
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Henri Becquerel
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie Becker, MD Centre Henri Becquerel
Principal Investigator: Florian Guisier, MD CHU Rouen
PRS Account Centre Henri Becquerel
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP