Using 18F-PD-L1 PET/CT to predict treatment response in lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multicenter, single-arm study aimed at exploring and validating biomarkers in patients with stage IV non-small cell lung cancer (NSCLC) who are eligible for first-line chemo-immunotherapy or PD-(L)1 immunotherapy. Eighty participants will undergo a whole-body 18F-PD-L1 PET/CT scan before starting nivolumab-containing treatment. The goal is to predict durable responses to treatment based on the PET/CT imaging results. Patients will continue their treatment until disease progression, withdrawal of consent, or unacceptable toxicity occurs.

Why it matters

Who can join: the full rules

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.

Where it's running

• MeanderMC
  Amersfoort, Netherlands Recruiting
• Antoni van Leeuwenhoek
  Amsterdam, Netherlands Recruiting
• Jeroen Bosch Ziekenhuis
  Den Bosch, Netherlands Recruiting
• Medisch Centrum Haaglanden
  Den Haag, Netherlands Recruiting
• Deventer Ziekenhuis
  Deventer, Netherlands Recruiting
• Lumc
  Leiden, Netherlands Recruiting

Study contacts

• Principal investigator: Joop de Langen, MD — The Netherlands Cancer Institute-Antoni van Leeuwenhoek
• Study coordinator: Joop de Langen, MD
• Email: j.d.langen@nki.nl
• Phone: +3120512

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.