NCT03832348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2024

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

February 5, 2019

Last Update Submit

December 29, 2025

Conditions

Non Small Cell Lung Cancer

Keywords

PET scan imagingPembrolizumabResponseParametric imaging

Outcome Measures

Primary Outcomes (1)

  • Determination of progression by early PET scan

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

    3 months

Secondary Outcomes (2)

  • Progression free survival

    24 months

  • Overall survival

    24 months

Study Arms (1)

PET scan imaging

EXPERIMENTAL

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

Interventions

PET scan imagingDEVICE

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

PET scan imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Henri Becquerel

Rouen, 76000, France

Location

CHU

Rouen, 76000, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stephanie Becker, MD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

  • Florian Guisier, MD

    CHU Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 6, 2019

Study Start

June 17, 2019

Primary Completion

June 3, 2024

Study Completion

July 3, 2024

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

FR(2)