Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects
NCT ID: NCT07175220
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-10-09
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Queue A
SHR2554; SHR-A2102
SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days
Queue B
SHR2554; Adabelimumab
SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days
Queue C
SHR2554; SHR-1701
SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days
Interventions
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SHR2554; SHR-A2102
SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days
SHR2554; Adabelimumab
SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days
SHR2554; SHR-1701
SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days
Eligibility Criteria
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Inclusion Criteria
2. Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology
3. ECOG score is 0 or 1
4. Expected survival period ≥ 12 weeks
5. Has a good level of organ function
6. Patients voluntarily joined the study and signed informed consent
Exclusion Criteria
2. Symptomatic or active central nervous system tumor metastasis
3. Previously or simultaneously suffering from other malignant tumors
4. Spinal cord compression that cannot be cured by surgery and/or radiotherapy
5. Accompanied by uncontrolled tumor related pain
6. Plan to receive any other anti-tumor treatment during this trial period
7. Receive other anti-tumor treatments within 4 weeks before the first medication
8. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration
9. 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
10. Moderate to severe pleural effusion with clinical symptoms
11. Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication
12. Subjects who have experienced severe infections within 30 days prior to their first medication use
13. Administer attenuated live vaccine within 30 days before the first use of medication.
14. History of immunodeficiency
15. Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases
16. History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past
17. AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1
18. Untreated active hepatitis
19. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
20. There are other serious physical or mental illnesses or laboratory abnormalities present
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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SHR2554-203-LC
Identifier Type: -
Identifier Source: org_study_id
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