New scan may reveal who will benefit from immunotherapy
NCT ID NCT03564197
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a new type of PET scan, which looks for a protein called PD-L1 on cancer cells, can predict how well patients with advanced lung cancer will respond to the immunotherapy drug nivolumab. Eighty patients received the scan before starting treatment. Researchers then tracked how long their cancer was controlled. The goal is to see if this imaging tool can help personalize treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-PD-L1 PET/CT scan (imaging tracer)
- What this could lead to
- If successful, this scan could help doctors identify which lung cancer patients are most likely to respond to immunotherapy, avoiding ineffective treatments.
- What could go wrong
- This is an early imaging study, not a treatment trial. The scan's accuracy may not be high enough to change clinical practice, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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80 people
The number who actually took part.
- Started
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Oct 2018
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 * 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. 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. 9. 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. 10. 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. 11. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 12. Has known active Hepatitis B or C.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Antoni van Leeuwenhoek
Amsterdam, 1060CX, Netherlands
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Antonius Ziekenhuis
Utrecht, Netherlands
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Deventer Ziekenhuis
Deventer, Netherlands
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
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LUMC
Leiden, Netherlands
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MeanderMC
Amersfoort, Netherlands
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Medisch Centrum Haaglanden
The Hague, Netherlands
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VUmc
Amsterdam, 1007 MB, Netherlands
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