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

Last updated date
Study Location
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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: January 14, 2020)
43
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2015)
130
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

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