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 |
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.
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.
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
3322 West End Avenue
Nashville, Tennessee 37203
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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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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