Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Device: PET scan imaging Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : March 17, 2022
Estimated Study Completion Date : December 17, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 24 months ]
    Time between inclusion and progression

  2. Overall survival [ Time Frame: 24 months ]
    Time between inclusion and death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Stephanie Becker, MD +33232888247 stephanie.becker@chb.unicancer.fr
Contact: Doriane Richard, PhD +33232082985 doriane.richard@chb.unicancer.fr

Locations
Layout table for location information
France
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Stephanie Becker, MD         
CHU Recruiting
Rouen, France, 76000
Contact: Luc Thiberville, Md, PhD         
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
Layout table for investigator information
Principal Investigator: Stephanie Becker, MD Centre Henri Becquerel
Principal Investigator: Florian Guisier, MD CHU Rouen
Layout table for additonal information
Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT03832348    
Other Study ID Numbers: CHB18.05
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Henri Becquerel:
PET scan imaging
Pembrolizumab
Response
Parametric imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms