Actively Recruiting
A Multicenter, Open Label Phase II Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Locally Advanced or Metastatic Non-small Cell Lung Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-11-18
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and objective response rate of SHR2554 tablets combined with other anti-tumor treatments in adults with locally advanced or metastatic non-small cell lung cancer. This phase II clinical trial aims to understand how well this combination works and its effects on this serious lung cancer condition. The study is sponsored by Jiangsu HengRui Medicine Co., Ltd. and follows an open-label, non-randomized design. The trial involves three experimental groups, each receiving SHR2554 tablets combined with a different anti-tumor treatment: SHR-A2102 injection, Adabelimumab, or SHR-1701 injection. Treatments are given in 21-day cycles. Participants receive these combinations while researchers monitor their health and response to the therapy over time. Participants will be closely followed with assessments of side effects, serious adverse events, and tumor response from the first dose until disease progression or death, up to three years. Additional measures include immune response testing, duration of tumor response, disease control rate, progression-free survival, and overall survival. Safety is tracked from the first dose through 30 days after the last dose. The total participation time can last up to three years, with regular monitoring throughout.
CONDITIONS
Brief 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...
- Age between 18 and 75 years old
- Diagnosed with locally advanced unresectable or metastatic non-small cell lung cancer confirmed by pathology
- ECOG performance status score of 0 or 1
- Expected survival period of at least 12 weeks
- Good organ function
- Voluntarily signed informed consent to join the study
You will not qualify if you...
- Difficulty swallowing, malabsorption syndrome, or uncontrolled gastrointestinal diseases
- History of gastrectomy or gastric banding surgery
- Symptomatic or active central nervous system tumor metastasis
- Other malignant tumors currently or previously
- Untreatable spinal cord compression
- Uncontrolled tumor-related pain
- Planning to receive other anti-tumor treatments during the trial
- Received other anti-tumor treatments within 4 weeks before first dose
- Major surgery within 28 days before first dose (except diagnosis or biopsy)
- Participation in another clinical study or medication less than 4 weeks after previous study
- Moderate to severe pleural effusion with symptoms
- Active pulmonary tuberculosis infection in past year
- Severe infections within 30 days before first dose
- Received attenuated live vaccine within 30 days before first dose
- History of immunodeficiency
- Severe or poorly controlled cardiovascular or cerebrovascular diseases
- History of interstitial or non-infectious pneumonia needing hormone therapy
- Side effects from previous anti-tumor treatment not recovered to mild level
- Untreated active hepatitis
- Female participants who are pregnant, breastfeeding, or planning pregnancy during study
- Other serious physical or mental illnesses or abnormal lab results present
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive SHR2554 tablets combined with other anti-tumor treatments in repeated 21-day cycles.
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xiaoxue Pi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here