Camrelizumab Plus Apatinib as Maintenance Therapy in Extensive-stage Small-cell Lung Cancer

Phase 2

• Conditions: Small Cell Lung Carcinoma
• Interventions: Drug: Camrelizumab Plus Apatinib

• Registration Number: NCT04901754
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

This single-arm, Phase II study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 \[PD-1\] antibody) combination with Apatinib in participants with ES-SCLC who was response or stable disease after firstline standard chemotherapy. Participants will be receive camrelizumab +apatinib on 21-day cycles 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-25
• Study Start: 2021-07-14
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-12-08
• Primary Completion: 2022-08-15
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Male or female patients aged 18 and 75 years old;
• Signed the informed consent form prior to patient entry;
• Eastern Cooperative Oncology Group performance status of 0 or 1;
• Expected Survival Time: Over 3 months;
• Pathological or cytologically proven extensive-Stage small cell lung cancer(according to Veterans Administration Lung Study Group)and without progression after Cycles 4-6 21-day cycles of first-line Standard chemotherapy(Evaluation was CR /PR/SD based on RECIST1.1);
• If prophylactic cranial irradiation (PCI) was not planned,informed consent was required to be written between 3 weeks and 5 weeks after day 1 of the last cycle of chemotherapy. If PCI was planned or already performe, informed consent was required to be written between 3 weeks and 8 weeks after day 1 of the last cycle of chemotherapy.

Exclusion Criteria

• Has prior therapy with anti-programmed cell death (PD)-1, anti-PD-L1,anti Cytotoxic T lymphocyte-associated Antigen(CTLA)-4 or other Drugs that target T cells;
• Has prior therapy with angiogenesis inhibitors,Such as sunitinib, bevacizumab, apatinib, anlotinib;
• Has active or untreated central nervous system (CNS) metastases and/or cancerous meningitis;
• Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
• Has spinal cord compression which was not cured or relieved through surgery and/or radiotherapy, or diagnosed spinal cord compression after treatment showed no clinical evidence of disease stabilization prior to allocation ≥1 week;
• Within the past 2 weeks have used high dose antibiotics;
• According to the judgement of the researchers, there are other factors that may lead to the termination of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab Plus Apatinib	Camrelizumab Plus Apatinib	camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally

Primary Outcome Measures

Name	Time	Method
Progression free survival(PFS)	up to 12 months	From the date of maintenance randomization to the date of first document of progression or symptomatic deterioration, or death due to any cause

Secondary Outcome Measures

Name	Time	Method
Overall survival(OS)	up to 24 months	From the date of maintenance randomization until death from any cause, with participants last known to be alive censored at the date of last contact

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China