A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC
NCT ID: NCT06754930
Last Updated: 2025-04-17
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
PHASE1/PHASE2
400 participants
INTERVENTIONAL
2025-02-18
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental group
SHR-1826
SHR-1826 for injection.
SHR-1316
SHR-1316 for injection.
SHR-9839
SHR-9839 for injection.
SHR-8068
SHR-8068 for injection.
Ametinib mesylate
Ametinib mesylate.
BP-102
BP-102 for injection.
Carboplatin
Carboplatin for injection.
Interventions
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SHR-1826
SHR-1826 for injection.
SHR-1316
SHR-1316 for injection.
SHR-9839
SHR-9839 for injection.
SHR-8068
SHR-8068 for injection.
Ametinib mesylate
Ametinib mesylate.
BP-102
BP-102 for injection.
Carboplatin
Carboplatin for injection.
Eligibility Criteria
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Inclusion Criteria
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed NSCLC.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate organ function.
9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
Exclusion Criteria
2. Previous or co-existing malignancies.
3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
4. Uncontrollable tumor-related pain.
5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy.
8. With poorly controlled or severe cardiovascular disease.
9. Active hepatitis B and hepatitis C.
10. Patients with a history of immunodeficiency.
11. Severe infection 30 days before the first dose.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-1826-201-LC
Identifier Type: -
Identifier Source: org_study_id
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