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18F-PD-L1 PET/CT in Nivolumab Treated Patients With NSCLC

18F-PD-L1 PET/CT to Predict Response to Nivolumab in Patients With NSCLC

NCT03564197•The Netherlands Cancer Institute

Summary

A multicenter single arm biomarker exploration and validation study. Eighty patients with NSCLC that are eligible for first line chemo-immunotherapy, first line nivolumab/ipilimumab or 2nd line and beyond PD-(L)1 immunotherapy monotherapy according to EMA label and national guidelines will be enrolled in this trial. All subjects will undergo a whole body 18F-PD-L1 PET/CT scan before start of nivolumab containing treatment. Patients will continue treatment until disease progression, withdrawal of patient consent or unacceptable toxicity.

Detailed Description

18F-PD-L1 PET/CT scan to predict durable reponse to nivolumab containing treatment in patients with NSCLC

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have a histologically or cytologically confirmed diagnosis of stage IV, EGFR WT and EML4-ALK fusion negative NSCLC. Mutational testing is not necessary in patients with squamous NSCLC.
•2. Eligible for first line chemo-immunotherapy, first line nivolumab + ipilimumab or 2nd line and beyond PD-(L)1 immunotherapy monotherapy.
•3. Be willing and able to provide written informed consent for the trial.
•4. Be \>= 18 years of age on day of signing informed consent.
•5. Have measurable disease based on RECIST 1.1.
•6. Must provide tissue from a histological biopsy of a tumor lesion that is not radiated prior to biopsy and obtained after the last line of systemic therapy, to determine the actual PD-L1 status.
•7. Have a performance status of 0-1 on the ECOG Performance Scale.
•8. Demonstrate adequate hematologic and organ function, defined by the following laboratory results. All screening laboratory tests should be performed within 30 days prior to day 1 (PET imaging):
•* Absolute neutrophil count (ANC) ≥ 1500 cells/µL
•* WBC count ≥ 2000 cells/µL
+5 more criteria

Exclusion Criteria

•1. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to day 1 (PET imaging). Inhaled or topical steroids, and adrenal replacement steroid \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
•2. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
•3. Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
•* Note: Subjects with asymptomatic CNS metastases are allowed to enter the study.
•* Note: Subjects with previously treated brain metastases may participate provided they are clinically stable and not using steroids with \> 10 mg daily prednisone equivalent for at least 7 days prior to trial treatment.
•4. Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
•5. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
•6. Has an active infection requiring systemic therapy.
•7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
•8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
+4 more criteria

Locations (8)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

MeanderMC

Amersfoort, Netherlands

VUmc

Amsterdam, Netherlands

Antoni van Leeuwenhoek

Amsterdam, Netherlands

Deventer Ziekenhuis

Deventer, Netherlands

LUMC

Leiden, Netherlands

Medisch Centrum Haaglanden

The Hague, Netherlands

Antonius Ziekenhuis

Utrecht, Netherlands

Key Dates

Start Date

October 25, 2018

Primary Completion Date

January 30, 2025

Completion Date

January 30, 2026

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

NSCLC Stage IV

Interventions

18F-PD-L1

OTHER

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

NCT06219317

NSCLC Stage IV

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RECRUITINGPHASE2

A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

NCT06947694

NSCLC Stage IV Without EGFR/ALK Mutation

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RECRUITINGPHASE2

Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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18F-PD-L1 PET/CT in Nivolumab Treated Patients With NSCLC

Inclusion Criteria

Exclusion Criteria

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases

Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

1st Line Durvalumab in PS 2 NSCLC Patients

Phase 2 Study of Dacomitinib in NSCLC