A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations (Balise)
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|ClinicalTrials.gov Identifier: NCT01897480|
Recruitment Status : Active, not recruiting
First Posted : July 12, 2013
Last Update Posted : December 4, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Progression Free Survival (PFS) [ Time Frame: Randomization to Objective Disease Progression or Death Due to Any Cause (Estimated 3 Years) ]
- Change in Tumor Size (CTS) [ Time Frame: Baseline to Measurement with Smallest Tumor Size (Estimated 3 Years) ]
- 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) ]
- 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) ]
- Time to Progressive Disease (TTPD) [ Time Frame: Randomization to Objective Disease Progression (Estimated 3 Years) ]
- 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) ]
- Overall Survival (OS) [ Time Frame: Randomization to Death Due to Any Cause (Estimated 5 Years) ]
- 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) ]
- 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) ]
- Proportion of Participants with Anti-LY2875358 Antibody Response [ Time Frame: Baseline through 30 Day Follow Up (Estimated 3 Years) ]
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 ClinicalTrials.gov identifier (NCT number): NCT01897480
Show 42 Study Locations
|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|