The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
This study will evaluate zipalertinib, a novel EGFR tyrosine kinase inhibitor (TKI) versus placebo in participants with resected early stage NSCLC harboring uncommon EGFRmt. Approximately 360 participants will be randomized to: Arm A: Zipalertinib twice daily (BID) monotherapy OR Arm B: Placebo BID monotherapy. An independent data monitoring committee (IDMC) will be established to monitor interim safety data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
Oral tablets.
Oral tablets.
Alaska Oncology and Hematology
Anchorage, Alaska, United States
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States
City of Hope Comprehensive Cancer Center Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Scripps Clinic Torrey Pines
La Jolla, California, United States
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, United States
Disease-free Survival (DFS) as Assessed by the Investigator
Time frame: Up to 5 years
Disease-free Survival Rate
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Overall Survival Rate
Time frame: Up to 5 years
DFS of Central Nervous System (cDFS)
Time frame: Up to 5 years
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Time frame: Up to 5 years
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to 5 years
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to 5 years
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 5 years
Number of Participants With Change in Left Ventricular Ejection Fraction (LVEF) Evaluated Using Electrocardiography (ECHO) and Multigated Acquisition (MUGA) Scan
Time frame: Up to 5 years
Change in EuroQuality of Life-5 Dimensional 3-Level (EQ-5D-3L)
EQ-5D-3L is a standardized measure of the participant's health-related quality of life (QoL). EQ-5D is a 5-item questionnaire that assesses 5 domains.
Time frame: Baseline, up to 5 years
Change From Baseline in European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scores
EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale.
Time frame: Up to 5 years
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Georgetown University School of Medicine
Washington D.C., District of Columbia, United States
D&H Cancer Research Center - Margate
Margate, Florida, United States
Alpha Oncology Research
Orange City, Florida, United States
City of Hope - Atlanta
Newnan, Georgia, United States
University of Illinois Medical Center
Chicago, Illinois, United States
...and 242 more locations