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NSCLC Stage IVNCT03564197

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

A study testing 18F-PD-L1 in people with NSCLC Stage IV, run by The Netherlands Cancer Institute at 8 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC Stage IV
What is being tested?
18F-PD-L1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
8 sitesNetherlands
Study dates
25 Oct 2018to 30 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Eligible for first line chemo-immunotherapy, first line nivolumab + ipilimumab or 2nd line and beyond PD-(L)1 immunotherapy monotherapy.
  • Be willing and able to provide written informed consent for the trial.
  • Be >= 18 years of age on day of signing informed consent.
  • Have measurable disease based on RECIST 1.1.
  • 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.
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  • Have a performance status of 0-1 on the ECOG Performance Scale.
  • 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
  • Platelet count ≥ 100.000/µL
  • Hemoglobin ≥ 5.6 mmol/L
  • AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastases are present)
  • Serum bilirubin ≤ 1.5 x ULN (except subjects with known Gilbert disease, who can have total bilirubin < 3.0 mg/dL)
  • Serum Creatinine ≤ 1.5 x ULN OR measured of calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥ 40 mL/min for subject with creatinine levels > 1.5 x ULN.

Who cannot join

  • 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.
  • 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.
  • 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.
  • 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.
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  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • 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.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B or C.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Netherlands8 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • MeanderMC

    Amersfoort

  • VUmc

    Amsterdam, 1007 MB

  • Antoni van Leeuwenhoek

    Amsterdam, 1060CX

  • Deventer Ziekenhuis

    Deventer

  • LUMC

    Leiden

  • Medisch Centrum Haaglanden

    The Hague

  • Antonius Ziekenhuis

    Utrecht

Other trials in Netherlands

About this study

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

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.

Read the detailed description

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

Conditions
NSCLC Stage IV
Being tested
18F-PD-L1
Keywords
EGFR WT, negative EML4-ALK fusion, eligible for first line chemo-immunotherapy, first line nivolumab/ipilimumab or 2nd line and beyond PD-(L)1 immunotherapy monotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-PD-L1Other

    Also called tracer

    18F-PD-L1 PET/CT scan

Study groups in NCT03564197
Study groupRoleWhat they receive
NivolumabOthernivolumab containing treatment according to label
Receives: Other: 18F-PD-L1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival of >= 9 months

    The outcome measures of 18F-PD-L1 PET/CT related to the progression-free survival at 9 months according to RECIST 1.1

    Measured: From date of registration until the date of progression-free survival >= 9 months (according to RECIST1.1)

Secondary outcomes (3)

  1. Progression Free Survival

    The outcome measures of 18F-PD-L1 PET/CT related to the date of the first documented tumor progression as determined by modified RECIST, or death due to any cause

    Measured: From date of registration until the date of first documented progression assessed up to 5 months

  2. Overall Survival

    The outcome measures of 18F-PD-L1 PET/CT related to the date of death due to any cause

    Measured: From date of registration until the date of death assessed up to 12 months

  3. Tumor and stromal PD-L1 IHC.

    Correlation between PD-L1 expression measured by 18F-PD-L1 PET/CT and PD-L1 expression measured by IHC

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start25 Oct 2018
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03564197
Sponsor's protocol ID
M17FNN
Other IDs
CA209-9XC
Status last verified
Feb 2026
First submitted
11 Apr 2018
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: to be decided

Questions about this trial

What is this clinical trial studying?

A study testing 18F-PD-L1 in people with NSCLC Stage IV, run by The Netherlands Cancer Institute at 8 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival of >= 9 months (time frame: From date of registration until the date of progression-free survival >= 9 months (according to RECIST1.1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03564197.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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