Clinical Trials /

Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)

NCT02584634

Description:

The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.

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

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)
  • Official Title: A PHASE 1B/2, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH EITHER CRIZOTINIB OR PF-06463922 IN PATIENTS WITH ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Clinical Trial IDs

  • ORG STUDY ID: B9991005
  • SECONDARY ID: 2015-001879-43
  • SECONDARY ID: JAVELIN LUNG 101
  • NCT ID: NCT02584634

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
AvelumabMSB0010718CGroup A
PF-06463922Group B
CrizotinibPF-02341066Group A

Purpose

The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.

Detailed Description

      This is a Phase 1b/2, open label, multi center, multiple dose, safety, pharmacokinetic and
      pharmacodynamic study of Group A and Group B in cohorts of adult patients with locally
      advanced or metastatic NSCLC.
    

Trial Arms

NameTypeDescriptionInterventions
Group AExperimentalALK negative Non-Small Cell Lung Cancer
  • Avelumab
  • Crizotinib
Group BExperimentalALK positive Non-Small Cell Lung Cancer
  • Avelumab
  • PF-06463922

Eligibility Criteria

        -  Inclusion Criteria

          -  Diagnosis of advanced or metastatic NSCLC. Group A must be ALK negative NSCLC and
             Group B must be ALK positive NSCLC

          -  Group A at least one prior regimen of therapy

          -  Group B any number of prior regimens.

          -  Mandatory tumor tissue available

          -  At least one measurable lesion

          -  ECOG Performance status 0 or 1

          -  Adequate bone marrow, renal, liver and pancreatic function

          -  Negative pregnancy test for females of childbearing potential

          -  Group B Phase 2: No prior systemic treatment for advanced or metastatic disease
             (adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months
             prior to study entry. No prior tyrosine kinase inhibitor therapy is allowed at any
             time prior to study entry)

        Exclusion Criteria:

          -  No prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
             antibody.

          -  No Severe or Chronic medical conditions including gastrointestinal abnormalities or
             significant cardiac history

          -  No active infection requiring systemic therapy

          -  Prior organ transplantation including allogenic stem cell transplantation.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:First two cycles dose limiting toxicities (DLTs) for Group A and Group B
Time Frame:28 days
Safety Issue:
Description:Complete response (CR) or Partial Response (PR) from start date (first dose of study treatment) until disease progression or death. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.

Secondary Outcome Measures

Measure:Disease Control (DC)
Time Frame:Up to 60 months.
Safety Issue:
Description:DC is defined as Best Overall Response of CR, PR, or Stable Disease (SD). Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.
Measure:Confirmed Overall Response (Group B)
Time Frame:Up to 60 months
Safety Issue:
Description:CR or PR from start date until disease progression or death. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.
Measure:Overall Survival
Time Frame:Up to 60 months
Safety Issue:
Description:Time from start date to the date of death due to any cause.
Measure:AUClast
Time Frame:Avelumab: Day 8, Crizotinib & PF-06463922: 24 hours
Safety Issue:
Description:Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (Clast)
Measure:AUCtau
Time Frame:Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1
Safety Issue:
Description:Area under the plasma concentration time profile after single dose from time zero to the next dose
Measure:Cmax
Time Frame:Avelumab: Day 1, Crizotinib & PF-06463922: Day 1
Safety Issue:
Description:Maximum observed plasma concentration
Measure:Tmax
Time Frame:Avelumab: Day 1, Crizotinib & PF-06463922: Day 1
Safety Issue:
Description:Time for Cmax
Measure:t½a
Time Frame:Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1
Safety Issue:
Description:Terminal half life
Measure:Ctrough
Time Frame:Avelumab: Day 1 pre-dose sample, Crizotinib & PF-06463922: Day 1
Safety Issue:
Description:Predose concentration during multiple dosing
Measure:CL/Fa
Time Frame:Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1
Safety Issue:
Description:Apparent clearance
Measure:Vz/Fa
Time Frame:Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1
Safety Issue:
Description:Apparent volume of distribution
Measure:MRAUCtau
Time Frame:Avelumab: Days 1 and 8, Crizotinib & PF=06463922: Day 1
Safety Issue:
Description:Metabolite to parent ratio for AUCtau
Measure:MRCmax
Time Frame:Avelumab: Day 1, Crizotinib & PF=06463922: Day 1
Safety Issue:
Description:Metabolite to parent ratio for Cmax
Measure:tumor tissue biomarkers
Time Frame:baseline
Safety Issue:
Description:Tumor tissue biomarkers, including but not limited to, PD-L1 expression and tumor infiltrating CD8+ T cells by immunohistochemistry (IHC)
Measure:Duration of Response (DR)
Time Frame:Up to 60 months
Safety Issue:
Description:DR is defined, for patients with an objective response, as the time from first documentation of objective response (CR or PR) to the date of first documentation of objective progression of disease or death due to any cause.
Measure:Time to Treatment Response (TTR)
Time Frame:Up to 60 months
Safety Issue:
Description:TTR is defined, for patients with an objective response, as the time from the start date to the first documentation of objective response (CR or PR) which is subsequently confirmed.
Measure:Progression Free Survival (PFS)
Time Frame:Up to 60 months
Safety Issue:
Description:PFS is defined as the time from start date to the date of the first documentation of PD or death due to any cause, whichever occurs first.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Pfizer

Trial Keywords

  • Non-Small Cell Lung Cancer
  • NSCLC
  • ALK
  • avelumab
  • crizotinib
  • PF-06463922

Last Updated

June 3, 2021