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A Study of LY2875358 in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)

This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: July 12, 2013
Last updated: April 25, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: LY2875358
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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) ]

Enrollment: 89
Study Start Date: August 2013
Study Completion Date: March 2016
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: LY2875358 plus Erlotinib
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.
Drug: LY2875358
Administered IV
Drug: Erlotinib
Administered Orally
Experimental: Arm B: LY2875358
750 mg LY2875358 flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
Drug: LY2875358
Administered IV


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01900652

  Show 59 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Study Director: 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) Eli Lilly and Company
  More Information

Responsible Party: Eli Lilly and Company Identifier: NCT01900652     History of Changes
Other Study ID Numbers: 14208
I4C-MC-JTBC ( Other Identifier: Eli Lilly and Company )
Study First Received: July 12, 2013
Last Updated: April 25, 2016

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017