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

NCT04901754 | Unknown Phase 2

• 1 other identifier: MA-SCLC-Ⅱ-002
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)

  From the date of maintenance randomization to the date of first document of progression or symptomatic deterioration, or death due to any cause

  up to 12 months

Secondary Outcomes (1)

• Overall survival(OS)

  up to 24 months

Other Outcomes (1)

• Adverse events (AEs)

  up to 24 month

Study Arms (1)

Camrelizumab Plus Apatinib

EXPERIMENTAL

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

Drug: Camrelizumab Plus Apatinib

Interventions

Camrelizumab Plus Apatinib 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.

Camrelizumab Plus Apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Qiming Wang, Doctor

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiming Wang, Doctor

CONTACT

0086-13783590691; qimingwang1006@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: July 14, 2021
• Primary Completion: August 15, 2022
• Study Completion: March 31, 2023
• Last Updated: December 8, 2021

Record last verified: 2021-03

Locations

CN (1)