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

Non Small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03832348
• Other study ID #: CHB18.05
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: December 17, 2023

Study information

• Verified date: July 2020
• Source: Centre Henri Becquerel
• Contact: Stephanie Becker, MD
• Phone: +33232888247
• Email: stephanie.becker[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 17, 2023
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Device:
• PET scan imaging
3 PET scans will be performed after each 3 first infusions of Pembrolizumab

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen
France	CHU	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival	Time between inclusion and progression	24 months
Secondary	Overall survival	Time between inclusion and death	24 months