Clinical Trial

A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma

Active, Not Recruiting Phase 3
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Record status
This record was last updated June 29, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
Main objectives: To evaluate the benefit of SI-B001+ docetaxel on overall survival (OS) of bidotaxel. To evaluate the benefit of SI-B001+ Docetaxel over Docetaxel's progression-free survival (PFS) based assessment. Secondary objectives: To evaluate the investigator-evaluated progression-free survival (PFS) benefit of SI-B001+ Docetaxel against docetaxel; To evaluate the difference of objective response rate (ORR), disease control rate (DCR) and duration of response (DOR) between SI-B001+ docetaxel and bidocetaxel. To evaluate the type, frequency and severity of adverse events (TEAE) and drug-related adverse events (TRAE) during treatment with SI-B001+ docetaxel in comparison with docetaxel. The pharmacokinetic (PK) characteristics of SI-B001 will be evaluated. The immunogenicity of SI-B001 will be evaluated. Subject quality of life.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-07-05; most recent amendment 2025-06-25.
Status change: Recruiting → Active, Not Recruiting 2025-06-25
Status change: Not Yet Recruiting → Recruiting 2023-08-16
Trial Details
NCT Number NCT05943795
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Conditions Non-small Cell Lung Adenocarcinoma, Squamous Cell Carcinoma of Lung
Enrollment 589 participants
Start Date 2023-07-14
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-06-29