Status:
RECRUITING
Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Locally Advanced or Metastatic Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 l...
Eligibility Criteria
Inclusion
- Age range of 18-75 years old (including both ends), gender not limited;
- Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology
- ECOG score is 0 or 1
- Expected survival period ≥ 12 weeks
- Has a good level of organ function
- Patients voluntarily joined the study and signed informed consent
Exclusion
- Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc
- Symptomatic or active central nervous system tumor metastasis
- Previously or simultaneously suffering from other malignant tumors
- Spinal cord compression that cannot be cured by surgery and/or radiotherapy
- Accompanied by uncontrolled tumor related pain
- Plan to receive any other anti-tumor treatment during this trial period
- Receive other anti-tumor treatments within 4 weeks before the first medication
- Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration
- Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study
- Moderate to severe pleural effusion with clinical symptoms
- Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication
- Subjects who have experienced severe infections within 30 days prior to their first medication use
- Administer attenuated live vaccine within 30 days before the first use of medication.
- History of immunodeficiency
- Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases
- History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past
- AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1
- Untreated active hepatitis
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- There are other serious physical or mental illnesses or laboratory abnormalities present
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07175220
Start Date
October 9 2025
End Date
October 1 2028
Last Update
November 18 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060