A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)

Lilly

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Emibetuzumab; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01900652

14208

I4C-MC-JTBC (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of metastatic Stage IV NSCLC
• At least 1 measurable extra-central nervous system (CNS) lesion
• Documented radiographic progression while on continuous treatment with erlotinib monotherapy
• Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
• Determined to be MET diagnostic positive (+)
• Availability of a tumor sample post-erlotinib progression
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Have adequate organ function

Exclusion criteria

• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
• Have previously been treated with LY2875358 or any other MET-targeting experimental therapeutic
• Have a serious concomitant systemic disorder or significant cardiac disease
• Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
• Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
• Have major surgery less than 2 weeks prior initiation of study treatment therapy
• Pregnant or lactating women
• Have symptomatic CNS metastasis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

111 participants in 2 patient groups

Arm A: Emibetuzumab plus Erlotinib

Experimental group

Description:

750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.

Treatment:

Drug: Erlotinib

Drug: Emibetuzumab

Arm B: Emibetuzumab

Experimental group

Description:

750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.

Treatment:

Drug: Emibetuzumab