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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2024-07-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer

NCT03774732

Non Small Cell Lung Cancer Non Small Cell Lung Cancer Metastatic Non-Small Cell Carcinoma of Lung, TNM Stage 4

RECRUITING PHASE3

Prognostic Value of Combined Approach Based on KEAP1/NFE2L2 Mutations and Pre-therapeutic FDG-PET/CT Radiomic Analysis in Advanced Non-small-cell Lung Cancer PDL1 ≥ 50% Treated With Pembrolizumab (PEMBROMIC)

NCT05996263

Lung Cancer Stage III Lung Cancer Stage IV

UNKNOWN

A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer

NCT03047616

Lung Cancer

COMPLETED

Early Response Evaluation in NSCLC Patients Treated With Immunotherapy

NCT04082988

NSCLC, Stage IV

TERMINATED NA

A Study With Pembrolizumab for Non-small Cell Lung Cancer (NSCLC)

NCT04393883

Non-small-lung-cell Cancer, NSCLC Pembrolizumab

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PET scan imaging

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.

Group Type EXPERIMENTAL

PET scan imaging

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PET scan imaging

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No