Description:
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.
Title
- Brief Title: Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy
- Official Title: A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation Who Progressed on or After Treatment With Platinum Based Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
HR-BLTN-III-NSCLC
- NCT ID:
NCT04447118
Conditions
- Non-squamous NSCLC
- HER2 Exon 20 Mutation
Interventions
Drug | Synonyms | Arms |
---|
Pyrotinib | Irene | Study treatment Arm |
Docetaxel | Docetaxel injection | Control Arm |
Purpose
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.
Detailed Description
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Study treatment Arm | Experimental | Pyrotinib maleate tablet, 400 mg, once daily (QD) | |
Control Arm | Active Comparator | Docetaxel injection, 75 mg/m2, once every 3 weeks (Q3W) | |
Eligibility Criteria
Inclusion Criteria:
- Signed and dated written informed consent which is approved by IRB/EC, willing and
able to comply with scheduled treatment, all examinations at study visits, and other
study procedures.
- ECOG PS 0-1.
- Have histologically or cytologically confirmed locally advanced or metastatic
non-squamous NSCLC disease.
- Before enrollment, a documented confirmed presence of activating mutations in exon 20
of the HER2 gene must be provided. Sufficient tumor tissue samples should be provided
to retrospectively confirm the mutation status of the HER2 gene.
- Must have measureable disease per RECIST v1.1.
- For advanced NSCLC, patients must have had progressive disease on or after a platinum
based chemotherapy, with or without immune checkpoint inhibitors (PD-1/PD-L1
inhibitors) and/or anti-angiogenic drugs. No more than 2 prior lines of systemic
therapy are allowed.
- The laboratory test values must meet the following standards to manifest that the
functional level of important organs/systems meets the requirements.
- Female patient of childbearing potential (WOCBP) and male patient whose - partner is
WOCBP must agree to use effective contraception method during the study period.
Exclusion Criteria:
- Malignant tumors with other pathological types.
- Medical history of other active malignancies within last 5 years.
- Subjects with active CNS metastases.
- Previously treated with targeted drugs for HER2 gene mutations,or previously treated
with docetaxel.
- Prior to the first dose of study treatment, patients with severe effusions with
clinical symptoms, severe cardiac disease, or severe infection.
- Prior to the first dose of study treatment, patients with diseases or special
conditions that affect drug administration and absorption.
- Congenital or acquired immunodeficiency.
- History of allergy to the study drugs or components.
- Prior to the first dose of study treatment, or during the study period, patients
receive or are anticipated to receive continuous strong CYP3A4 inducers or inhibitors,
P-gp inhibitors, or medications that are known to cause QT/QTc prolongation.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (PFS) |
Time Frame: | 26 months |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | Time from the date of randomization to death for any cause. |
Measure: | Objective response rate (ORR) |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Assessed by BIRC and investigator according to the RECIST v1.1. |
Measure: | Disease control rate (DCR) |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Assessed by BIRC and investigator according to the RECIST v1.1. |
Measure: | Duration of response (DoR) |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Assessed by BIRC and investigator according to the RECIST v1.1. |
Measure: | Time to tumor progression (TTP) |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Assessed by BIRC and investigator according to the RECIST v1.1. |
Measure: | Progression-free survival 2(PFS2) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | Assessed by investigator according to the RECIST v1.1, or death for any cause, whichever comes first. |
Measure: | Patient reported outcome (PRO) using EORTC QLQ-C30 |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Symptoms related to NSCLC, |
Measure: | Patient reported outcomes (PRO) using the QLQ-LC13 |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Symptoms related to NSCLC |
Measure: | Plasma concentrations of pyrotinib |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Pharmacokinetics (PK) of pyrotinib |
Measure: | AEs and SAEs |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Judged in accordance with NCI-CTCAE v5.0 |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Jiangsu HengRui Medicine Co., Ltd. |
Trial Keywords
- pyrotinib
- docetaxel
- HER2 Exon 20 Mutation
- NSCLC
Last Updated
March 25, 2021