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NOT YET RECRUITING
NCT05882630
PHASE1/PHASE2

Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

To evaluates the effectiveness and safety of Surufatinib combined with Serplulimab plus chemotherapy for the first-line treatment of ES-SCLC, and maintenance therapy are Surufatinib combined with Serplulimab

Official title: Surufatinib Combined With Serplulimab Plus Carboplatin and Etoposide as First-line Treatment for Extensive-stage Small-cell Lung Cancer:a Multicenter, Open-label, Phase I/II Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2023-06-01

Completion Date

2026-06-01

Last Updated

2023-05-31

Healthy Volunteers

No

Interventions

DRUG

Surufatinib,Serplulimab,Etoposide,Carboplatin

In dose escalation, Surufatinib will be administered orally (PO) once daily (QD) ,d1-21,q3w + Serplulimab 4.5 mg/kg ivgtt,d1,q3w+Etoposide 100mg/m2,d1-3,q3w + Carboplatin AUC=5,d1,q3w; 4-6 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21,q3w+Serplulimab 4.5 mg/kg ivgtt,d1,q3w+Etoposide 100mg/m2,d1-3,q3w + Carboplatin AUC=5,d1,q3w, 4-6 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21,q3w+Serplulimab 4.5 mg/kg ivgtt,d1,q3w until the disease progressed.

Locations (1)

Fujian Cancer Hospital

Fuzhou, Fujian, China