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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01900652
First received: July 12, 2013
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • Time to Progressive Disease (TTPD) [ Time Frame: Baseline to Objective Disease Progression (Estimated up to 24 Months) ] [ Designated as safety issue: No ]
  • Change in Tumor Size (CTS) [ Time Frame: Baseline to Measurement with Smallest Tumor Size (Estimated up to 24 Months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Baseline to Death Due to Any Cause (Estimated up to 24 Months) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Proportion of Participants with Anti-LY2875358 Antibody Response [ Time Frame: Baseline through 30 Day Follow Up (Estimated up to 24 Months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: July 2018
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01900652

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 72 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01900652     History of Changes
Other Study ID Numbers: 14208, I4C-MC-JTBC
Study First Received: July 12, 2013
Last Updated: August 29, 2014
Health Authority: European Union: European Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products
France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
South Korea: Korea Food and Drug Administration (KFDA)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014