The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer
Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Time frame: From first dose date to progression/death or last tumor assessment, up to three years.
Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer
Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease \>= 12 Weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: From first dose date to progression/death or last tumor assessment, up to three years.
Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer
Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Time frame: From start date of response to first PD, assessed up to three years after the first randomization.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Massachusetts General Hospital, Yawkey Center for Outpatient Care
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Memorial Sloan-Kettering
New York, New York, United States
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Swedish Cancer Institute
Seattle, Washington, United States
...and 9 more locations
Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From first dose date to progression/death, assessed up to three years.