NCT06754930 A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC
| NCT ID | NCT06754930 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Non-small Cell Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2027-12 |
Trial Parameters
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Brief Summary
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.
Eligibility Criteria
Inclusion Criteria: 1. Voluntary participation and written informed consent. 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: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 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 th
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