A Study of LY3023414 and Necitumumab in Squamous Lung Cancer

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLY3023414 and Necitumumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 9, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Eli Lilly and Company
Interventions being studied: Drug: LY3023414; Drug: Necitumumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Southern Cancer Center, P.C.Mobile, Alabama
Ironwood Cancer & Research CentersChandler, Arizona
Comprehensive Cancer Care and Research Institute of ColoradoEnglewood, Colorado
Florida Cancer SpecialistsFort Myers, Florida
Florida Hospital Cancer InstituteOrlando, Florida
Florida Cancer SpecialistsSt. Petersburg, Florida
Palm Beach Cancer InstituteWest Palm Beach, Florida
Research Medical CenterKansas City, Missouri
Oncology Hematology Care Inc.Cincinnati, Ohio
Chattanooga Oncology HematologyChattanooga, Tennessee
SMO Sarah Cannon Research Inst.Nashville, Tennessee
Tennessee OncologyNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 9, 2020. Always confirm current availability with the study team.

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