NCT04996771

Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in the Treatment of Small Cell Lung Cancer

A Phase Ⅰb/II Study of Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in Patients With Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluates the effectiveness and safety of Surufatinib combined with chemotherapy plus Toripalimab or not for the first-line treatment of SCLC, and maintenance therapy are Surufatinib combined with Toripalimab or not.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib,Etoposide,Cisplatin,Toripalimab	In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 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＋Toripalimab 240mg,d1,q3w was taken orally until the disease progressed.
DRUG	Surufatinib,Etoposide,Cisplatin	In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 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 was taken orally until the disease progressed.

Timeline

• Start date: 2021-11-09
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-08-09
• Last updated: 2022-11-14

Locations

1 site across 1 country: China