Clinical Trials /

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

NCT03564197

Description:

A multicenter single arm biomarker exploration and validation study. Eighty patients with NSCLC that are eligible for nivolumab treatment 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 nivolumab treatment. Patients will continue treatment with nivolumab according to label until disease progression, withdrawal of patient consent or unacceptable toxicity.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 18F-PD-L1 PET/CT in Nivolumab Treated Patients With NSCLC
  • Official Title: 18F-PD-L1 PET/CT to Predict Response to Nivolumab in Patients With NSCLC

Clinical Trial IDs

  • ORG STUDY ID: M17FNN
  • SECONDARY ID: CA209-9XC
  • NCT ID: NCT03564197

Conditions

  • NSCLC Stage IV

Purpose

A multicenter single arm biomarker exploration and validation study. Eighty patients with NSCLC that are eligible for nivolumab treatment 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 nivolumab treatment. Patients will continue treatment with nivolumab according to label until disease progression, withdrawal of patient consent or unacceptable toxicity.

Detailed Description

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

Trial Arms

NameTypeDescriptionInterventions
NivolumabOthernivolumab treatment according to label

    Eligibility 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 nivolumab treatment according to EMA label and national guidelines.
    
              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. 9.
    
              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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The objective response rate as defined by RECIST
    Time Frame:From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 months
    Safety Issue:
    Description:The outcome measures of 18F-PD-L1 PET/CT related to the objective response rate as defined by RECIST

    Secondary Outcome Measures

    Measure:PFS
    Time Frame:From date of registration until the date of first documented progression assessed up to 5 months
    Safety Issue:
    Description: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
    Measure:OS
    Time Frame:From date of registration until the date of death assessed up to 12 months
    Safety Issue:
    Description:The outcome measures of 18F-PD-L1 PET/CT related to the date of death due to any cause
    Measure:Tumor and stromal PD-L1 IHC.
    Time Frame:Through study completion, an average of 2 years
    Safety Issue:
    Description:Correlation between PD-L1 expression measured by 18F-PD-L1 PET/CT and PD-L1 expression measured by IHC

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:The Netherlands Cancer Institute

    Trial Keywords

    • EGFR WT
    • negative EML4-ALK fusion
    • eligible for nivolumab treatment

    Last Updated