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)
NCT ID: NCT02584634
Last Updated: 2023-07-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
43 participants
INTERVENTIONAL
2015-12-18
2022-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
ALK negative Non-Small Cell Lung Cancer
Avelumab
Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg
Crizotinib
Capsules. Taken orally once or twice every day in doses of either 200mg or 250mg.
Group B
ALK positive Non-Small Cell Lung Cancer
Avelumab
Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg
PF-06463922
Tablets taken orally once every day in doses of either 100mg, 75mg, or 50mg.
Interventions
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Avelumab
Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg
PF-06463922
Tablets taken orally once every day in doses of either 100mg, 75mg, or 50mg.
Crizotinib
Capsules. Taken orally once or twice every day in doses of either 200mg or 250mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston Inc (OCB)
Boston, Massachusetts, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Aichi cancer center central hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, , Japan
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Institut Catala d'Oncologia de Badalona
Badalona, Barcelona, Spain
Hospital Quiron Barcelona
Barcelona, , Spain
Hospital Universitari de la Vall d'Hebron
Barcelona, , Spain
Countries
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References
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Solomon BJ, Dagogo-Jack I, Lee SH, Boyer MJ, Ramalingam SS, Carcereny E, Felip E, Han JY, Hida T, Hughes BGM, Kim SW, Nishio M, Seto T, Okamoto T, Zhang X, Martini JF, Wang E, De Beukelaer S, Bauer TM. Avelumab in Combination With Lorlatinib or Crizotinib in Patients With Previously Treated Advanced NSCLC: Phase 1b/2 Results From the JAVELIN Lung 101 Trial. JTO Clin Res Rep. 2024 May 16;5(7):100685. doi: 10.1016/j.jtocrr.2024.100685. eCollection 2024 Jul.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2015-001879-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JAVELIN LUNG 101
Identifier Type: OTHER
Identifier Source: secondary_id
B9991005
Identifier Type: -
Identifier Source: org_study_id
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