This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy.
150 eligible subjects will be randomized in a 2:1 ratio (Study treatment Arm: Control Arm = 100 : 50 subjects) to receive pyrotinib or docetaxel monotherapy. Each treatment cycle is defined as 21 days for subjects in both arms. Treatment regimen of pyrotinib (Study treatment Arm): 400 mg/d (QD) oral pyrotinib will be administered within 30 minutes after completion of a meal. Treatment regimen of docetaxel (Control Arm): 75 mg/m2 (Q3W) of docetaxel will be administered via intravenous infusion. In this study, crossover treatment is allowed for subjects in Control Arm. Within the specified time window of each cycle, subjects should complete physical examinations, laboratory tests, quality of life questionnaires and other tests to assess the safety and quality of life of the subjects. During study treatment, tumor radiological assessments will be performed every 6 weeks (42 ± 7 days) in the first 52 weeks and every 12 weeks (84 ± 7 days) thereafter. After the end of treatment and safety follow-up, all subjects will be followed for survival (every 56 ± 7 days) until death, withdrawal of informed consent, lost to follow-up, or termination of the study (whichever occurs first).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
151
400 mg, once daily (QD), will be administered with water within 30 minutes after completion of a meal, at approximately the same time each day on a continuous daily dosing schedule, with 21 days as a cycle.
75 mg/m2, once every 3 weeks (Q3W), will be administered by intravenous infusion over 1 hour, with 21 days as a cycle.
Progression-free survival (PFS)
Time from the date of randomization to the date of first disease progression documented by BIRC according to the RECIST v1.1 or death for any cause, whichever comes first.
Time frame: 26 months
Overall survival (OS)
Time from the date of randomization to death for any cause.
Time frame: 36 months
Objective response rate (ORR)
Assessed by BIRC and investigator according to the RECIST v1.1.
Time frame: 26 months
Disease control rate (DCR)
Assessed by BIRC and investigator according to the RECIST v1.1.
Time frame: 26 months
Duration of response (DoR)
Assessed by BIRC and investigator according to the RECIST v1.1.
Time frame: 26 months
Time to tumor progression (TTP)
Assessed by BIRC and investigator according to the RECIST v1.1.
Time frame: 26 months
Progression-free survival 2(PFS2)
Assessed by investigator according to the RECIST v1.1, or death for any cause, whichever comes first.
Time frame: 36 months
Patient reported outcome (PRO) using EORTC QLQ-C30
Symptoms related to NSCLC,
Time frame: 26 months
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University of California - Irvine Medical Center
Orange, California, United States
University of California (UC) Davis Comprehensive Cancer Center
Sacramento, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Florida Cancer Specialists South Divisio
Fort Myers, Florida, United States
Florida Cancer Specialists North Divisio
St. Petersburg, Florida, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
...and 92 more locations
Patient reported outcomes (PRO) using the QLQ-LC13
Symptoms related to NSCLC
Time frame: 26 months
Plasma concentrations of pyrotinib
Pharmacokinetics (PK) of pyrotinib
Time frame: 26 months
AEs and SAEs
Judged in accordance with NCI-CTCAE v5.0
Time frame: 26 months