NCT04683198

Camrelizumab Combined With Apatinib ,Carboplatin and Etoposide in Participants With ES-SCLC

A Single -Arm, Open-label, Multicenter Phase II Study of Camrelizumab Combined With Apatinib ,Carboplatin and Etoposide in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This single-arm, Phase II, multicenter study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 \[PD-1\] antibody) in combination with Apatinib+carboplatin plus (+) etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be receive camrelizumab +apatinib+ carboplatin + etoposide on 21-day cycles for four -six cycles in the induction phase followed by maintenance with camrelizuab +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.

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	camrelizumab	Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6) and maintenance phase ,until PD.
DRUG	Apatinib Mesylate	Apatinib capsules 250 mg given orally , once daily in 21-day cycle and maintenance phase,until PD.
DRUG	Carboplatin	Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6).
DRUG	Etoposide	Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6).

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-10-30
• Completion: 2024-06-30
• First posted: 2020-12-24
• Last updated: 2020-12-24