Back to resultsCamrelizumab Plus Apatinib as Maintenance Therapy in Extensive-stage Small-cell Lung Cancer (CAMERA)
Primary Purpose
Small Cell Lung Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab Plus Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Carcinoma focused on measuring Maintenance, Camrelizumab Plus Apatinib
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.
Sites / Locations
- Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Camrelizumab Plus Apatinib
Arm Description
camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall survival(OS)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04901754
Brief Title
Camrelizumab Plus Apatinib as Maintenance Therapy in Extensive-stage Small-cell Lung Cancer
Acronym
CAMERA
Official Title
Camrelizumab Plus Apatinib as Maintenance Treatment in Extensive-stage SCLC With a Response or Stable Disease After Standard Chemotherapy: A Single-arm, Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma
Keywords
Maintenance, Camrelizumab Plus Apatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camrelizumab Plus Apatinib
Arm Type
Experimental
Arm Description
camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally
Intervention Type
Drug
Intervention Name(s)
Camrelizumab Plus Apatinib
Intervention Description
-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.
Primary Outcome Measure Information:
Title
Progression free survival(PFS)
Description
From the date of maintenance randomization to the date of first document of progression or symptomatic deterioration, or death due to any cause
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Overall survival(OS)
Description
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
Time Frame
up to 24 months
Other Pre-specified Outcome Measures:
Title
Adverse events (AEs)
Description
All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0
Time Frame
up to 24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiming Wang, Doctor
Phone
0086-13783590691
Email
qimingwang1006@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiming Wang, Doctor
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiming Wang, Doctor
Phone
0086-13783590691
Email
qimingwang1006@126.com
12. IPD Sharing Statement
Learn more about this trial
Camrelizumab Plus Apatinib as Maintenance Therapy in Extensive-stage Small-cell Lung Cancer
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