A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations (Balise)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01897480
Recruitment Status : Active, not recruiting
First Posted : July 12, 2013
Last Update Posted : December 4, 2018
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: LY2875358 Drug: Erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment With Erlotinib
Actual Study Start Date : August 28, 2013
Actual Primary Completion Date : March 14, 2016
Estimated Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LY2875358 plus Erlotinib

Lead In: Approximately 8 weeks of erlotinib 150 milligram (mg) given orally per day.

Randomization: Erlotinib 150 mg given orally per day plus 750 mg LY2875358 given as 1.5 hours intravenous (IV) infusions on Days 1 and 15 of 28-day cycles.

Biological: LY2875358
Administered IV

Drug: Erlotinib
Administered Orally

Active Comparator: Erlotinib

Lead In: Approximately 8 weeks of erlotinib 150 mg given orally per day.

Randomization: Continue Erlotinib 150 mg given orally per day, in 28-day cycles.

Drug: Erlotinib
Administered Orally

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years) ]

Secondary Outcome Measures :
  1. Change in Tumor Size (CTS) [ Time Frame: Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years) ]
  2. 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 3 Years) ]
  3. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years) ]
  4. Time to Progressive Disease (TTPD) [ Time Frame: Randomization to Objective Disease Progression (Estimated 3 Years) ]
  5. 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 3 Years) ]
  6. Overall Survival (OS) [ Time Frame: Randomization to Death Due to Any Cause (Estimated 5 Years) ]
  7. 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 3 Years) ]
  8. Pharmacokinetics (PK): Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) of LY2875358 and Erlotinib [ Time Frame: Baseline through Cycle 4 (28 Day Cycle) ]
  9. Proportion of Participants with Anti-LY2875358 Antibody Response [ Time Frame: Baseline through 30 Day Follow Up (Estimated 3 Years) ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC
  • Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
  • Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q)
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Haven't received any prior systemic chemotherapy for Stage IV NSCLC (unless received as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment)
  • Availability of adequate tumor material (block or slides)

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 completed or withdrawn from this study or any other study investigating LY2875358
  • 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 to the initiation of study treatment therapy
  • Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01897480

  Show 42 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

Responsible Party: Eli Lilly and Company Identifier: NCT01897480     History of Changes
Other Study ID Numbers: 14209
I4C-MC-JTBB ( Other Identifier: Eli Lilly and Company )
2012-005476-33 ( EudraCT Number )
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018

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