A Study of LY3023414 and Necitumumab in Squamous Lung Cancer
NCT ID: NCT02443337
Last Updated: 2020-12-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
31 participants
INTERVENTIONAL
2015-07-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LY3023414 + Necitumumab
200 milligrams (mg) LY3023414 administered orally twice daily and 800 mg necitumumab administered intravenously (IV) on day 1 and day 8 of each cycle (21 day cycles). Participants may continue to receive treatment until discontinuation criteria are met.
LY3023414
Administered orally
Necitumumab
Administered IV
Interventions
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LY3023414
Administered orally
Necitumumab
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have progressed on one prior line of platinum-based chemotherapy in the advanced or metastatic setting.
* Measurable disease as measured by response evaluation criteria in solid tumors (RECIST) criteria v 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Able to swallow the study drugs whole.
* Adequate organ function.
* Women of childbearing potential must have a negative serum or urine pregnancy test performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 3 months following completion of study treatment.
Exclusion Criteria
* Prior treatment with a PI3K/mTOR inhibitor, epidermal growth factor receptor (EGFR) inhibitor, and/or necitumumab.
* History of brain metastases unless irradiated ≥ 2 weeks prior to first study treatment and stable without requirement of corticosteroids.
* Have serious pre-existing medical conditions.
* Have insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetics.
* Women who are pregnant or breast-feeding.
* Clinically significant electrolyte imbalance ≥ Grade 2.
* Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular weight heparin and oral Xa inhibitors are allowed.
* Have initiated treatment with bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ≤ 28 days prior to Day 1 of Cycle 1.
* Concurrent serious infection requiring parenteral antibiotic therapy.
* Have a second primary malignancy that in the judgment of the investigator and Medical Monitor may affect the interpretation of results.
* Have an active, known fungal, bacterial, and/or known viral infection.
* History of arterial or venous embolism within 3 months prior to study enrollment. If the embolism occurred \>3 and \<6 months, the participant is eligible provided appropriate treatment according to institutional standard of care is ensured.
18 Years
ALL
No
Sponsors
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SCRI Development Innovations, LLC
OTHER
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Southern Cancer Center, P.C.
Mobile, Alabama, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Comprehensive Cancer Care and Research Institute of Colorado
Englewood, Colorado, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Research Medical Center
Kansas City, Missouri, United States
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States
Chattanooga Oncology Hematology
Chattanooga, Tennessee, United States
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
University of Virginia Health
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of LY3023414 and Necitumumab in Squamous Lung Cancer
Other Identifiers
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I6A-MC-CBBE
Identifier Type: OTHER
Identifier Source: secondary_id
15799
Identifier Type: -
Identifier Source: org_study_id