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

NCT ID: NCT04901754

Last Updated: 2021-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-14
• Study Completion Date: 2023-03-31

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.

Conditions

Small Cell Lung Carcinoma

Keywords

Maintenance; Camrelizumab Plus Apatinib

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab Plus Apatinib

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

Group Type: EXPERIMENTAL

Camrelizumab Plus Apatinib

Intervention Type: DRUG

-Drug: camrelizumab Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle,until PD.

Other Name: SHR-1210

-Drug: Apatinib Mesylate Apatinib capsules 250 mg given orally , once daily in 21-day cycle ,until PD.

Interventions

Camrelizumab Plus Apatinib

-Drug: camrelizumab Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle,until PD.

Other Name: SHR-1210

-Drug: Apatinib Mesylate Apatinib capsules 250 mg given orally , once daily in 21-day cycle ,until PD.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiming Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiming Wang, Doctor

Role: CONTACT

Phone: 0086-13783590691

Email: qimingwang1006@126.com

Facility Contacts

Qiming Wang, Doctor

Role: primary

Other Identifiers

MA-SCLC-Ⅱ-002

Identifier Type: -

Identifier Source: org_study_id