NCT05020457

SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC.

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Chemotherapy in the Treatment of EGFR WT and ALK WT Recurrent and Metastatic Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, open label phase II clinical study is performed in patients with locally advanced or metastatic EGFR wild-type ALK wild-type non-small cell lung cancer progressed on prior anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with chemotherapy in patients.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SI-B001	SI-B001 is administered by intravenous drip once weekly (QW). 120 min ± 10 min after the first intravenous drip, if the infusion reaction is tolerable during the first dose, the subsequent infusion can be completed within 60-120 min (unless agreed or required by the investigator, the infusion time can be extended), if SI-B001 and chemotherapy are used on the same day, the infusion of chemotherapeutic drugs should be continued after the completion of SI-B001 infusion.
DRUG	AP or TP	AP or TP should be administered immediately after SI-B001 is completed. The administration of AP or TP should refer to the drug instructions and standard usage.
DRUG	Docetaxel	Docetaxel should be administered immediately after SI-B001 is completed. The administration of Docetaxel should refer to the drug instructions and standard usage.

Timeline

• Start date: 2021-12-07
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-08-25
• Last updated: 2025-09-26

Locations

6 sites across 1 country: China