Status:
ACTIVE_NOT_RECRUITING
A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2...
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- advanced non-small cell lung cancer with HER2 expression , amplification, or mutation
- has previously received platinum-based chemotherapy for advanced or metastatic NSCLC, has developed disease progression during or after treatment, or is unable to tolerate platinum-based chemotherapy.
- There is at least one measurable lesion according to RECIST V1.1 criteria
Exclusion
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
- Has received HER2 antibody drug conjugates,
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- Has active infection requiring systemic treatment.
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT04818333
Start Date
April 23 2021
End Date
June 1 2025
Last Update
June 13 2024
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030