A Study of LY3023414 and Necitumumab in Squamous Lung Cancer

Lilly

Status and phase: Terminated; Phase 2

Conditions: Non-small Cell Lung Cancer Metastatic

Treatments: Drug: LY3023414; Drug: Necitumumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02443337

I6A-MC-CBBE (Other Identifier)

15799

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

LY3023414 + Necitumumab

Experimental group

Description:

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.

Treatment:

Drug: LY3023414

Drug: Necitumumab