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Trial record 1 of 1 for:    NCT02584634
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02584634
Recruitment Status : Active, not recruiting
First Posted : October 22, 2015
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 21, 2015
First Posted Date  ICMJE October 22, 2015
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE December 18, 2015
Estimated Primary Completion Date March 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2015)
  • First two cycles dose limiting toxicities (DLTs) for Group A and Group B [ Time Frame: 28 days ]
  • Confirmed Overall Response (OR) per RECIST v.1.1 for Group A [ Time Frame: Up to 60 months ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02584634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2015)
  • Disease Control (DC) [ Time Frame: Up to 60 months. ]
    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.
  • Confirmed Overall Response (Group B) [ Time Frame: Up to 60 months ]
    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.
  • Overall Survival [ Time Frame: Up to 60 months ]
    Time from start date to the date of death due to any cause.
  • AUClast [ Time Frame: Avelumab: Day 8, Crizotinib & PF-06463922: 24 hours ]
    Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (Clast)
  • AUCtau [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
    Area under the plasma concentration time profile after single dose from time zero to the next dose
  • Cmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF-06463922: Day 1 ]
    Maximum observed plasma concentration
  • Tmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF-06463922: Day 1 ]
    Time for Cmax
  • t½a [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
    Terminal half life
  • Ctrough [ Time Frame: Avelumab: Day 1 pre-dose sample, Crizotinib & PF-06463922: Day 1 ]
    Predose concentration during multiple dosing
  • CL/Fa [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
    Apparent clearance
  • Vz/Fa [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
    Apparent volume of distribution
  • MRAUCtau [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF=06463922: Day 1 ]
    Metabolite to parent ratio for AUCtau
  • MRCmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF=06463922: Day 1 ]
    Metabolite to parent ratio for Cmax
  • tumor tissue biomarkers [ Time Frame: baseline ]
    Tumor tissue biomarkers, including but not limited to, PD-L1 expression and tumor infiltrating CD8+ T cells by immunohistochemistry (IHC)
  • Duration of Response (DR) [ Time Frame: Up to 60 months ]
    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.
  • Time to Treatment Response (TTR) [ Time Frame: Up to 60 months ]
    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.
  • Progression Free Survival (PFS) [ Time Frame: Up to 60 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Avelumab
    Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg
    Other Name: MSB0010718C
  • Drug: PF-06463922
    Tablets taken orally once every day in doses of either 100mg, 75mg, or 50mg.
  • Drug: Crizotinib
    Capsules. Taken orally once or twice every day in doses of either 200mg or 250mg.
    Other Name: PF-02341066
Study Arms  ICMJE
  • Experimental: Group A
    ALK negative Non-Small Cell Lung Cancer
    Interventions:
    • Drug: Avelumab
    • Drug: Crizotinib
  • Experimental: Group B
    ALK positive Non-Small Cell Lung Cancer
    Interventions:
    • Drug: Avelumab
    • Drug: PF-06463922
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 14, 2018)
42
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2015)
130
Estimated Study Completion Date  ICMJE March 5, 2020
Estimated Primary Completion Date March 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Japan,   Korea, Republic of,   Spain,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT02584634
Other Study ID Numbers  ICMJE B9991005
2015-001879-43 ( EudraCT Number )
JAVELIN LUNG 101 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP