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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

December 7, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Non Small Cell Lung Cancer
Interventions
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.

Trial Locations (6)

510075

Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou

Unknown

Chongqing University Cancer Hospital, Chongqing

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

The Second Affiliated Hospital of Guilin Medical University, Guilin

Shandong Cancer Hospital, Jinan

TaiZhou Hospital of Zhejiang Province, Taizhou

All Listed Sponsors
lead

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY