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Early Response Evaluation in NSCLC Patients Treated With Immunotherapy

NCT04082988 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-10-10

No results posted yet for this study

Summary

A pilot study with biomarker exploration.50 patients with stage IV non-small cell lung cancer (NSCLC) that are eligible for treatment with nivolumab. Patients will undergo a 18F-FDG-PET/CT and EBUS-FNA of the lymph nodes and have blood drawn before and after immune checkpoint inhibitor treatment to compare tumor FDG uptake and to identify changes in the immune effector cell subsets in TDLNs. Blood will be drawn in parallel to compare the distribution of immune effector cell subsets before and after treatment initiation. Because of the possible burden for patients, the EBUS-FNA is not mandatory to complete the study and is there for an exploratory objective. Also blood will be drawn for a tumor mutational burden at baseline. The first six patients will undergo a dynamic PET-CT scan in addition to a static scan to study the influence of possible immunotherapy induced changes to the body distribution and kinetics of FDG..

Conditions

  • NSCLC, Stage IV

Interventions

DIAGNOSTIC_TEST

18F-FDG PET-CT

18F-FDG PET-CT scan

Sponsors & Collaborators

Principal Investigators

  • J de Langen, MD, PhD · NKI-AvL

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-23
Primary Completion
2020-05-22
Completion
2020-05-22

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04082988 on ClinicalTrials.gov