Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatments ly2875358, erlotinib
Phase phase 2
Targets c-MET, EGFR
Sponsor Eli Lilly and Company
Start date August 2013
End date February 2015
Trial size 100 participants
Trial identifier NCT01900652, 14208, I4C-MC-JTBC

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
750 milligram (mg) LY2875358 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.
ly2875358
Administered IV
erlotinib
Administered Orally
(Experimental)
750 mg LY2875358 flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
ly2875358
Administered IV

Primary Outcomes

Measure
Proportion of Participants Exhibiting a Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
time frame: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Estimated up to 15 Months)

Secondary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Baseline to Objective Disease Progression or Death Due to Any Cause (Estimated up to 24 Months)
Time to Progressive Disease (TTPD)
time frame: Baseline to Objective Disease Progression (Estimated up to 24 Months)
Change in Tumor Size (CTS)
time frame: Baseline to Measurement with Smallest Tumor Size (Estimated up to 24 Months)
Proportion of Participants Exhibiting a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate [DCR])
time frame: Baseline to Objective Disease Progression or Participant Stops Study (Estimated up to 24 Months)
Duration of Response (DoR)
time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 24 Months)
Overall Survival (OS)
time frame: Baseline to Death Due to Any Cause (Estimated up to 24 Months)
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) C30 (QLQ-C30) and Lung Cancer 13 (QLQ-LC13)
time frame: Baseline, Objective Disease Progression or Participants Stops Study (Estimated up to 24 Months)
Change from Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
time frame: Baseline, Objective Disease Progression or Participants Stops Study (Estimated up to 24 Months)
Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358
time frame: Cycle 1 through Cycle 4 (28 Day Cycle)
Proportion of Participants with Anti-LY2875358 Antibody Response
time frame: Baseline through 30 Day Follow Up (Estimated up to 24 Months)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.