search
Back to results

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

Primary Purpose

Non Small Cell Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET scan imaging
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non Small Cell Lung Cancer focused on measuring PET scan imaging, Pembrolizumab, Response, Parametric imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Henri BecquerelRecruiting
  • CHURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET scan imaging

Arm Description

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.

Outcomes

Primary Outcome Measures

Determination of progression by early PET scan
Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab

Secondary Outcome Measures

Progression free survival
Time between inclusion and progression
Overall survival
Time between inclusion and death

Full Information

First Posted
February 5, 2019
Last Updated
July 29, 2020
Sponsor
Centre Henri Becquerel
search

1. Study Identification

Unique Protocol Identification Number
NCT03832348
Brief Title
Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment
Acronym
iTEP1
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
March 17, 2022 (Anticipated)
Study Completion Date
December 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
PET scan imaging, Pembrolizumab, Response, Parametric imaging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET scan imaging
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
PET scan imaging
Intervention Description
3 PET scans will be performed after each 3 first infusions of Pembrolizumab
Primary Outcome Measure Information:
Title
Determination of progression by early PET scan
Description
Determination of non-response of treatment by PET scan imaging after one cycle of Pembrolizumab
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Time between inclusion and progression
Time Frame
24 months
Title
Overall survival
Description
Time between inclusion and death
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Becker, MD
Phone
+33232888247
Email
stephanie.becker@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Becker, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Florian Guisier, MD
Organizational Affiliation
CHU Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Becker, MD
Facility Name
CHU
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Thiberville, Md, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs