Actively Recruiting
Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-11-18
200
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer
CONDITIONS
Official Title
Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years old, any gender
- Diagnosed with locally advanced unresectable or metastatic non-small cell lung cancer confirmed by pathology
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Good organ function levels
- Voluntarily agree to participate and provide informed consent
You will not qualify if you...
- Difficulty swallowing, malabsorption syndrome, or uncontrolled gastrointestinal diseases
- History of gastrectomy or gastric banding surgery
- Active or symptomatic central nervous system tumor metastasis
- Current or previous diagnosis of other malignant tumors
- Untreatable spinal cord compression
- Uncontrolled tumor-related pain
- Planned or ongoing other anti-tumor treatments during the study
- Anti-tumor treatments received within 4 weeks before starting this study
- Major surgery other than diagnosis or biopsy within 28 days before first dose
- Participation in other clinical studies or first medication less than 4 weeks after prior study
- Moderate to severe pleural effusion with symptoms
- Active pulmonary tuberculosis infection within one year before starting treatment
- Severe infections within 30 days before starting treatment
- Received attenuated live vaccine within 30 days before treatment
- History of immunodeficiency
- Poorly controlled or severe cardiovascular and cerebrovascular diseases
- History of interstitial or non-infectious pneumonia needing hormone therapy
- Previous anti-tumor treatment adverse events not resolved to mild or better
- Untreated active hepatitis
- Pregnant, breastfeeding, or planning pregnancy during the study
- Other serious physical or mental illnesses or abnormal lab results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xiaoxue Pi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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