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

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ClinicalTrials.gov Identifier: NCT03564197
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
NSCLC Stage IV Other: 18F-PD-L1 Not Applicable

Detailed Description:
18F-PD-L1 PET/CT scan to predict durable reponse to nivolumab containing treatment in patients with NSCLC
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-PD-L1 PET/CT to Predict Response to Nivolumab in Patients With NSCLC
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : October 25, 2021
Estimated Study Completion Date : October 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Nivolumab
nivolumab containing treatment according to label
 Other: 18F-PD-L1
18F-PD-L1 PET/CT scan
Other Name: tracer


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    The outcome measures of 18F-PD-L1 PET/CT related to the progression-free survival at 9 months according to RECIST 1.1


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: From date of registration until the date of first documented progression assessed up to 5 months ]
    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

  2. Overall Survival [ Time Frame: From date of registration until the date of death assessed up to 12 months ]
    The outcome measures of 18F-PD-L1 PET/CT related to the date of death due to any cause

  3. Tumor and stromal PD-L1 IHC. [ Time Frame: Through study completion, an average of 2 years ]
    Correlation between PD-L1 expression measured by 18F-PD-L1 PET/CT and PD-L1 expression measured by IHC


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564197


Contacts
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Contact: Joop de Langen, MD +3120512 ext 9111 j.d.langen@nki.nl
Contact: Marianne Mahn, MSc +3120512 ext 2974 m.mahn@nki.nl

Locations
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Netherlands
MeanderMC Recruiting
Amersfoort, Netherlands
Contact: Judith Herder, MD, PhD         
VUmc Not yet recruiting
Amsterdam, Netherlands, 1007 MB
Contact: Idris Bahce, MD    +3120444 ext 4782    i.bahce@vumc.nl   
Antoni van Leeuwenhoek Recruiting
Amsterdam, Netherlands, 1060CX
Contact: Joop de Langen, MD, PhD         
Jeroen Bosch Ziekenhuis Recruiting
Den Bosch, Netherlands
Contact: Bonne Biesma, MD, PhD       b.biesma@jbz.nl   
Medisch Centrum Haaglanden Recruiting
Den Haag, Netherlands
Contact: K Maas, MD       k.maas@mchaaglanden.nl   
Deventer Ziekenhuis Recruiting
Deventer, Netherlands
Contact: S. Samii, MD       s.samii@dz.nl   
LUMC Recruiting
Leiden, Netherlands
Contact: Jasper Smit, MD         
Antonius Ziekenhuis Recruiting
Utrecht, Netherlands
Contact: Lisanne Kastelijn, MD, PhD         
Sponsors and Collaborators
The Netherlands Cancer Institute
Bristol-Myers Squibb
Investigators
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Principal Investigator: Joop de Langen, MD The Netherlands Cancer Institute-Antoni van Leeuwenhoek
Principal Investigator: Egbert Smit, MD The Netherlands Cancer Institute-Antoni van Leeuwenhoek
More Information
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT03564197    
Other Study ID Numbers: M17FNN
CA209-9XC ( Other Identifier: Bristol-Myers Squibb )
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to be decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
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
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases