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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

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

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Avelumab Drug: PF-06463922 Drug: Crizotinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 18, 2015
Estimated Primary Completion Date : March 5, 2020
Estimated Study Completion Date : March 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Group A
ALK negative Non-Small Cell Lung Cancer
Drug: Avelumab
Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg
Other Name: MSB0010718C

Drug: Crizotinib
Capsules. Taken orally once or twice every day in doses of either 200mg or 250mg.
Other Name: PF-02341066

Experimental: Group B
ALK positive Non-Small Cell Lung Cancer
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.




Primary Outcome Measures :
  1. First two cycles dose limiting toxicities (DLTs) for Group A and Group B [ Time Frame: 28 days ]
  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Overall Survival [ Time Frame: Up to 60 months ]
    Time from start date to the date of death due to any cause.

  4. 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)

  5. 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

  6. Cmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF-06463922: Day 1 ]
    Maximum observed plasma concentration

  7. Tmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF-06463922: Day 1 ]
    Time for Cmax

  8. t½a [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
    Terminal half life

  9. Ctrough [ Time Frame: Avelumab: Day 1 pre-dose sample, Crizotinib & PF-06463922: Day 1 ]
    Predose concentration during multiple dosing

  10. CL/Fa [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
    Apparent clearance

  11. Vz/Fa [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF-06463922: Day 1 ]
    Apparent volume of distribution

  12. MRAUCtau [ Time Frame: Avelumab: Days 1 and 8, Crizotinib & PF=06463922: Day 1 ]
    Metabolite to parent ratio for AUCtau

  13. MRCmax [ Time Frame: Avelumab: Day 1, Crizotinib & PF=06463922: Day 1 ]
    Metabolite to parent ratio for Cmax

  14. 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)

  15. 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.

  16. 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.

  17. 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.



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
  • 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.

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): NCT02584634


Locations
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United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory Investigational Drug Service
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Ophthalmic Consultants of Boston Inc (OCB)
Boston, Massachusetts, United States, 02114
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Japan
Aichi cancer center central hospital
Nagoya, Aichi, Japan, 464-8681
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Korea, Republic of
National Cancer Center
Goyang-Si, Gyeonggi-do, Korea, Republic of, 10408
Asan Medical Center
Seoul, Korea, Republic of, 05505
Clinical Research Pharmacy, Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Spain
Institut Catala d'Oncologia de Badalona,Unidad de Farmacia Oncologica-Ensayos Clinicos
Badalona, Barcelona, Spain, 08916
Institut Catala d'Oncologia de Badalona
Badalona, Barcelona, Spain, 08916
Hospital Quiron Barcelona
Barcelona, Spain, 08023
Hospital Universitari de la Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02584634     History of Changes
Other Study ID Numbers: B9991005
2015-001879-43 ( EudraCT Number )
JAVELIN LUNG 101 ( Other Identifier: Alias Study Number )
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Non-Small Cell Lung Cancer
NSCLC
ALK
avelumab
crizotinib
PF-06463922

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Crizotinib
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action