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

Centre Henri Becquerel

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Device: PET scan imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03832348

CHB18.05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

PET scan imaging

Experimental group

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.

Treatment:

Device: PET scan imaging