A Study of LY3023414 and Necitumumab in Squamous Lung Cancer

Stopped early · Phase 2

Conditions studied: Non-small Cell Lung Cancer Metastatic

In brief

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).

Key facts

Study ID

NCT02443337

Run by

Eli Lilly and Company

People needed

31

Starts

2015-07-01

Expected to finish

2017-09-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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