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Completed

NCT Number: NCT03832348

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Rouen, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET scan imaging

Device

3 PET scans will be performed after each 3 first infusions of Pembrolizumab

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study 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

Acronym: iTEP1

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2019
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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