Actively Recruiting
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-20
324
Participants Needed
2
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
CONDITIONS
Official Title
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and comply with study procedures
- Aged 18 to 75 years, any gender
- ECOG performance status 0 or 1
- Expected survival of at least 12 weeks
- Diagnosed with advanced or metastatic non-small cell lung cancer
- Provide tumor tissue samples (formalin fixed or unstained)
- Have failed or are intolerant to prior standard care
- Have at least one measurable lesion
- Vital organs functioning well
- Good heart function
- Agree to use birth control
You will not qualify if you...
- Untreated or active central nervous system tumor metastases
- Pleural, ascites, or pericardial effusion needing intervention within 7 days before treatment
- Systemic antitumor therapy within 4 weeks before study start
- Prior treatment with antibody-conjugated drugs
- Chest radiation over 30 Gy within 6 months before treatment
- Palliative radiotherapy within 7 days before treatment
- Not recovered from toxicity of previous treatments to mild or less
- Using certain CYP3A4 inhibitors or inducers with insufficient washout period
- Systemic immunosuppressant therapy within 14 days before study
- Known or suspected interstitial pneumonia
- Gastrointestinal issues affecting drug absorption within 28 days before treatment
- Active or suspected autoimmune disease
- Poorly controlled or severe cardiovascular disease
- Previous or concurrent malignancy
- Severe infection within 28 days before first dose
- Active hepatitis B
- Active tuberculosis within 1 year before enrollment
- History of immunodeficiency
- Live attenuated vaccine within 28 days before or expected during study
- Participation in another clinical study with recent dosing
- Major surgery other than biopsy within 28 days before treatment
- Allergic to SHR-A1811, Pyrotinib, SHR-1316, or related components
- History of severe allergic reactions to similar drugs
- Female pregnancy, breastfeeding, or plans to become pregnant during study
- Uncontrolled mental illness or substance abuse
- Any condition that increases risk or interferes with study as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Chest hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
S
Suqiang Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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