A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
Status: | Completed |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/27/2018 |
Start Date: | August 2013 |
End Date: | March 2016 |
A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib
The primary purpose of this study is to evaluate the efficacy of the study drug known as
LY2875358, administered alone or in combination with a second drug named Erlotinib, in
participants affected by a defined type of lung cancer (MET biomarker diagnostic positive
Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent
treatment with Erlotinib.
LY2875358, administered alone or in combination with a second drug named Erlotinib, in
participants affected by a defined type of lung cancer (MET biomarker diagnostic positive
Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent
treatment with Erlotinib.
Inclusion Criteria:
- Diagnosis of metastatic Stage IV NSCLC
- At least 1 measurable extra-central nervous system (CNS) lesion
- Documented radiographic progression while on continuous treatment with erlotinib
monotherapy
- Objective clinical benefit from erlotinib treatment as defined by either documented
partial or complete response or stable disease ≥6 months or, if most recent erlotinib
treatment has been initiated based on documented epidermal growth factor receptor
mutation (EGFRmt) status, at least 12 weeks stable disease
- Determined to be MET diagnostic positive (+)
- Availability of a tumor sample post-erlotinib progression
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Have adequate organ function
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical
trial involving an investigational product or non-approved use of a drug or device
- Have previously been treated with LY2875358 or any other MET-targeting experimental
therapeutic
- Have a serious concomitant systemic disorder or significant cardiac disease
- Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural
effusion, pericardial fluids or ascites, requiring drainage every other week or more
frequently
- Have a history of another malignancy except for basal or squamous cell skin cancer
and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and
without evidence of recurrence for at least 3 years prior to the study
- Have major surgery less than 2 weeks prior initiation of study treatment therapy
- Pregnant or lactating women
- Have symptomatic CNS metastasis
We found this trial at
33
sites
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
Tacoma, Washington 98405
(253) 403-5200
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
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