Status:
COMPLETED
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
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Non-squamous NSCLC
HER2 Exon 20 Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-...
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 day...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04447118
Start Date
September 11 2020
End Date
December 6 2024
Last Update
December 19 2025
Active Locations (102)
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1
University of California - Irvine Medical Center
Orange, California, United States, 92868
2
University of California (UC) Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
Innovative Clinical Research Institute
Whittier, California, United States, 33756
4
Florida Cancer Specialists South Divisio
Fort Myers, Florida, United States, 33901