drugset / Trial / NCT04453930

A Study of Sequential Therapy of Camrelizumab Combined With Chemotherapy(Irinotecan Plus Platinum)and With Apatinib in Participants With Untreated Advanced Small Cell Lung Cancer(SCLC)

NCT04453930 ↗

Phase 2 Unknown 60 enrolled Peking Union Medical College Hospital
NaSingle-groupOpen-labelTreatment

Summary

This single arm, open label, single center, prospective study was designed to evaluate the safety and efficacy of Sequential Therapy of Camrelizumab (humanized monoclonal antibody against Programmed death 1 \[PD-1\] ) in combination with Chemotherapy(Irinotecan plus Platinum)and with Apatinib (selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor \[TKI\]) in chemotherapy-naive participants with SCLC. Participants will receive Camrelizumab + Irinotecan + Platinum on 21-day cycles for 4-6 cycles in the induction phase followed by maintenance with Camrelizumab + Apatinib until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

Timeline

Start
2020-06-08
Primary completion
2023-06
Completion
2023-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Rivoceranib Small molecule 250 mg —
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified 30 mg/m2 Intravenous
Background Irinotecan Small molecule 65 mg/m2 Intravenous