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)



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:December 18, 2015
End Date:March 5, 2020

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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

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

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.

- 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.
We found this trial at
10
sites
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, GA
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Atlanta, Georgia 30322
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Atlanta, Georgia 30322
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Boston, Massachusetts 02114
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Camperdown, New South Wales 2050
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Camperdown,
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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