A Study of LY3023414 and Necitumumab in Squamous Lung Cancer



Status:Terminated
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/20/2018
Start Date:July 2015
End Date:September 1, 2017

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A Phase II Study of the Combination of LY3023414 and Necitumumab After First-Line Chemotherapy for Metastatic Squamous Non-small Cell Carcinoma of the Lung

The main purpose of this study is to evaluate the safety and activity of the study drug known
as LY3023414 in combination with necitumumab in participants with metastatic squamous
non-small cell lung cancer (NSCLC).


Inclusion Criteria:

- Histologically confirmed squamous advanced NSCLC (Stage IV).

- 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:

- Participants who have received > 1 prior line of chemotherapy in the advanced or
metastatic setting. (Immunotherapy will not be considered a line of chemotherapy.)

- 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.
We found this trial at
14
sites
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Melissa Johnson
Phone: 312-695-3511
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Michael McCleod
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Chandler, Arizona 85224
Principal Investigator: Mikhail Shtivelband
Phone: 480-821-2838
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Charlottesville, Virginia 22908
Principal Investigator: Richard Hall
Phone: 434-924-3627
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Chattanooga, Tennessee 37404
Principal Investigator: Davey Daniel
Phone: 423-698-1844
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: David Waterhouse
Phone: 513-891-4800
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Englewood, Colorado 80113
Principal Investigator: D Trevarthen
Phone: 303-788-8675
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Fort Worth, Texas 76104
Principal Investigator: Ray Page
Phone: 817-759-7023
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Principal Investigator: Jaswinder Singh
Phone: 816-276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Mobile, Alabama 36608
Principal Investigator: Michael Meshad
Phone: 251-433-9899
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Nashville, Tennessee 37203
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Orlando, Florida 32804
Principal Investigator: Tarek Mekhail
Phone: 407-303-2000
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Saint Petersburg, Florida 33705
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West Palm Beach, Florida 33401
Principal Investigator: Todd Gersten
Phone: 561-366-4131
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