Study Stopped
The study stopped due to lack of efficacy.
A Study of LY3023414 and Necitumumab in Squamous Lung Cancer
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
2 other identifiers
interventional
31
1 country
14
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2015
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
December 9, 2020
CompletedDecember 9, 2020
January 1, 2018
2.2 years
May 11, 2015
October 5, 2020
November 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at 6 Months: Disease Control Rate (DCR)
RECIST v 1.1 was used to assess tumor response.The 6-month DCR was defined as the number of participants with PFS \> 6 months (or 26 weeks, to accommodate the scheduled tumor assessment at week 24 be delayed by up to 2 weeks) divided by number of participants with baseline tumor assessment. Target Lesions:CR was defined as the disappearance of all target lesions. PR was at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest (nadir) sum of diameters since the treatment started. Non-Target Lesions:CR was defined as disappearance of all non-target lesions and normalization of tumor markers.All lymph nodes must be non-pathological in size (\<10 millimeters(mm) short axis).SD was defined as the persistence of one or more non-target lesions and/or persistence of tumor marker level above the normal limits.
6 Months
Secondary Outcomes (5)
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
Baseline to Objective Disease Progression or Initiation of Subsequent Anticancer Therapy (Up To 3 Months)
Progression Free Survival (PFS)
Enrollment to Measured Progressive Disease or Death from Any Cause (Up To 12 Months)
Overall Survival (OS)
Enrollment to Death from Any Cause (Up To 16 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3023414 and Necitumumab
Cycle 1 Day 8, and Cycle 3 Day 8 (pre-dose, end of necitumumab infusion and 1 hour post-necitumumab infusion), Cycle 2 Day 1, Cycle 4 Day 1
Pharmacokinetics: Maximum Concentration (Cmax) of LY3023414 and Necitumumab
Cycle 1 Day 8, and Cycle 3 Day 8 (pre-dose, end of necitumumab infusion and 1 hour post-necitumumab infusion)
Study Arms (1)
LY3023414 + Necitumumab
EXPERIMENTAL200 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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- SCRI Development Innovations, LLCcollaborator
Study Sites (14)
Southern Cancer Center, P.C.
Mobile, Alabama, 36608, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
Comprehensive Cancer Care and Research Institute of Colorado
Englewood, Colorado, 80113, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Oncology Hematology Care Inc.
Cincinnati, Ohio, 45242, United States
Chattanooga Oncology Hematology
Chattanooga, Tennessee, 37404, United States
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, 37203, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
University of Virginia Health
Charlottesville, Virginia, 22908, United States
Related Links
MeSH Terms
Interventions
Limitations and Caveats
The study stopped due to lack of efficacy.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 13, 2015
Study Start
July 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
December 9, 2020
Results First Posted
December 9, 2020
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.