Clinical trial NCT02443337: A Study of LY3023414 and Necitumumab in Squamous Lung Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Metastatic
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: SCRI Development Innovations, LLC
First posted: 2015-05-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at 6 Months: Disease Control Rate (DCR)
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
timeFrame: Baseline to Objective Disease Progression or Initiation of Subsequent Anticancer Therapy (Up To 3 Months)
measure: Progression Free Survival (PFS)
timeFrame: Enrollment to Measured Progressive Disease or Death from Any Cause (Up To 12 Months)
measure: Overall Survival (OS)
timeFrame: Enrollment to Death from Any Cause (Up To 16 Months)
measure: Pharmacokinetics (PK): Minimum Concentration (Cmin) of LY3023414 and Necitumumab
timeFrame: 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
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3023414 and Necitumumab
timeFrame: Cycle 1 Day 8, and Cycle 3 Day 8 (pre-dose, end of necitumumab infusion and 1 hour post-necitumumab infusion)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center, P.C.
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Englewood
country: United States
facility: Comprehensive Cancer Care and Research Institute of Colorado
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc.
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology
state: Tennessee
city: Nashville
country: United States
facility: SMO Sarah Cannon Research Inst.
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Fort Worth
country: United States
facility: Center for Cancer and Blood Disorders
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: