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A Study of LY3023414 and Necitumumab in Squamous Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02443337
Recruitment Status : Terminated (The observed DCR at 6 months is 4%,below the hypothesized 44% DCR at 6 months as the primary objective of this study. The study stopped due to lack of activity.)
First Posted : May 13, 2015
Last Update Posted : September 12, 2019
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Metastatic Drug: LY3023414 Drug: Necitumumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2015
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Necitumumab

Arm Intervention/treatment
Experimental: 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.
Drug: LY3023414
Administered orally

Drug: Necitumumab
Administered IV
Other Names:
  • LY3012211
  • IMC-11F8

Primary Outcome Measures :
  1. Percentage of Participants with a Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3023414 and Necitumumab [ Time Frame: Predose Cycle 1 through End of Study Treatment (Approximately 5 Months) ]
  2. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) [ Time Frame: Baseline to Objective Disease Progression (Approximately 3 Months) ]
  3. Progression Free Survival [ Time Frame: Baseline to Measured Progressive Disease or Death from Any Cause (Approximately 6 Months) ]
  4. Overall Survival [ Time Frame: Baseline to Death from Any Cause (Approximately 9 Months) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02443337

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United States, Alabama
Southern Cancer Center, P.C.
Mobile, Alabama, United States, 36608
United States, Arizona
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
United States, Colorado
Comprehensive Cancer Care and Research Institute of Colorado
Englewood, Colorado, United States, 80113
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, Ohio
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Chattanooga Oncology Hematology
Chattanooga, Tennessee, United States, 37404
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
United States, Virginia
University of Virginia Health
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Eli Lilly and Company
SCRI Development Innovations, LLC
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Study Director: 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) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company Identifier: NCT02443337     History of Changes
Other Study ID Numbers: 15799
I6A-MC-CBBE ( Other Identifier: Eli Lilly and Company )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs