Actively Recruiting
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-01-21
300
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
CONDITIONS
Official Title
A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide a written informed consent
- Aged between 18 and 75 years (inclusive)
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed advanced or metastatic Non-Small Cell Lung Cancer
- Central laboratory-confirmed functional HER2 mutations
- No prior systemic antitumor therapy for advanced or metastatic NSCLC
- At least one measurable lesion outside the central nervous system meeting RECIST v1.1 criteria
- Adequate organ function including cardiac, renal, and hepatic function as defined by the protocol
You will not qualify if you...
- Mixed lung cancer with small cell components or sarcomatoid carcinoma confirmed by histology or cytology
- Carrying other driver gene mutations with approved targeted drugs
- Untreated or active central nervous system tumor metastases, history of meningeal metastasis, or current meningeal metastasis
- Poorly controlled tumor-related pain
- Previous or current other malignancies
- History or current interstitial pneumonia/non-infectious pneumonia requiring hormone therapy
- Active or previous autoimmune diseases
- Uncontrolled or severe cardiovascular diseases
- Active hepatitis B or hepatitis C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
Y
You Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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