Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone for First-line Treatment in Subjects With Programmed Death Ligand 1 (PD-L1) Positive Relapsed or Advanced Non-small Cell Lung Cancer (NSCLC)
Primary Purpose
PD-L1 Positive Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Camrelizumab 200mg
Apatinib Mesylate 250mg
Pemetrexed disodium for injection
Paclitaxel injection
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for PD-L1 Positive Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects who have recurrent or advanced (Stage IIIB-IV) non-small cell lung cancer confirmed by histology or cytology.
- No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
- Subjects should not have a previously detected activating Epidermal Growth Factor Receptor (EFGR) mutation or Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
- Subjects must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
- Freshly acquired samples or archived specimens within 6 months before randomization must be provided.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion Criteria:
- Radiologically confirmed central squamous cell carcinoma.
- Untreated central nervous system metastases (such as brain or meningeal metastases).
- Pleural effusion, pericardial effusion, or ascites with clinical symptoms that need drainage
- Past or present with idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonia (eg bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia during CT screening, or objective evidence of severe impairment of lung function
- Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
- Subjects with suspected active tuberculosis should be examined for chest X-rays, sputum, and ruled out by clinical signs and symptoms.
- Uncontrolled Cardiac Symptoms or Diseases.
- Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
- Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-cytotoxic T lymphocyte antigen-4 monoclonal antibody, or vascular endothelial growth factor receptor (VEGFR) small molecule inhibitor therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Camrelizumab 200mg + Apatinib Mesylate 250mg
Camrelizumab 200mg
Pemetrexed/Paclitaxel injection+ Carboplatin
Arm Description
Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
Camrelizumab 200mg q2w ivgtt
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) assessed by Independent review committee (IRC)
Progression Free Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurs first.
Overall survival
Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up
Secondary Outcome Measures
PFS assessed by investigator
Progression-Free-Survival
Objective Response Rate
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points
Disease Control Rate
Disease Control Rate, determined using RECIST v1.1 criteria
Duration of Response
Duration of Response, determined using RECIST v1.1 criteria
Time to Treatment Failure
Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
Adverse Events and Serious Adverse Events
Adverse Events and Serious Adverse Events
Full Information
NCT ID
NCT04203485
First Posted
December 13, 2019
Last Updated
May 7, 2020
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04203485
Brief Title
Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone for First-line Treatment in Subjects With Programmed Death Ligand 1 (PD-L1) Positive Relapsed or Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title
A Randomized, Open-Label, Controlled, Multicenter Phase III Study of Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone Versus Platinum-based Chemotherapy for First-line Treatment in Subjects With PD-L1 Positive Relapsed or Advanced NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PD-L1 Positive Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
762 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Camrelizumab 200mg + Apatinib Mesylate 250mg
Arm Type
Experimental
Arm Description
Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
Arm Title
Camrelizumab 200mg
Arm Type
Experimental
Arm Description
Camrelizumab 200mg q2w ivgtt
Arm Title
Pemetrexed/Paclitaxel injection+ Carboplatin
Arm Type
Active Comparator
Arm Description
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
Intervention Type
Biological
Intervention Name(s)
Camrelizumab 200mg
Intervention Description
Camrelizumab 200mg q2w ivgtt
Intervention Type
Drug
Intervention Name(s)
Apatinib Mesylate 250mg
Intervention Description
Apatinib Mesylate 250mg po qd
Intervention Type
Drug
Intervention Name(s)
Pemetrexed disodium for injection
Intervention Description
Pemetrexed disodium for injection 500 mg/m2 q3w
Intervention Type
Drug
Intervention Name(s)
Paclitaxel injection
Intervention Description
Paclitaxel injection 175 mg/m2 q3w
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 5 mg/mL/min q3w
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) assessed by Independent review committee (IRC)
Description
Progression Free Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurs first.
Time Frame
up to 2 years
Title
Overall survival
Description
Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
PFS assessed by investigator
Description
Progression-Free-Survival
Time Frame
up to 2 years
Title
Objective Response Rate
Description
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points
Time Frame
At the time point of every 6 weeks,up to 2 years
Title
Disease Control Rate
Description
Disease Control Rate, determined using RECIST v1.1 criteria
Time Frame
At the time point of every 6 weeks,up to 2 years
Title
Duration of Response
Description
Duration of Response, determined using RECIST v1.1 criteria
Time Frame
Up to 2 years
Title
Time to Treatment Failure
Description
Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
Time Frame
Up to 2 years
Title
Adverse Events and Serious Adverse Events
Description
Adverse Events and Serious Adverse Events
Time Frame
from the first drug administration to within 90 days for the last Camrelizumab dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who have recurrent or advanced (Stage IIIB-IV) non-small cell lung cancer confirmed by histology or cytology.
No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
Subjects should not have a previously detected activating Epidermal Growth Factor Receptor (EFGR) mutation or Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
Subjects must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
Freshly acquired samples or archived specimens within 6 months before randomization must be provided.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion Criteria:
Radiologically confirmed central squamous cell carcinoma.
Untreated central nervous system metastases (such as brain or meningeal metastases).
Pleural effusion, pericardial effusion, or ascites with clinical symptoms that need drainage
Past or present with idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonia (eg bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia during CT screening, or objective evidence of severe impairment of lung function
Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
Subjects with suspected active tuberculosis should be examined for chest X-rays, sputum, and ruled out by clinical signs and symptoms.
Uncontrolled Cardiac Symptoms or Diseases.
Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-cytotoxic T lymphocyte antigen-4 monoclonal antibody, or vascular endothelial growth factor receptor (VEGFR) small molecule inhibitor therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanren Wang, PhD
Phone
18036618570
Email
wangquanren@hrglobe.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Weixia Li, Master
Phone
15005136260
Email
liweixia@hrglobe.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
33323401
Citation
Zhou C, Wang Y, Zhao J, Chen G, Liu Z, Gu K, Huang M, He J, Chen J, Ma Z, Feng J, Shi J, Yu X, Cheng Y, Yao Y, Chen Y, Guo R, Lin X, Wang Z, Gao G, Wang Q, Li W, Yang X, Wu L, Zhang J, Ren S. Efficacy and Biomarker Analysis of Camrelizumab in Combination with Apatinib in Patients with Advanced Nonsquamous NSCLC Previously Treated with Chemotherapy. Clin Cancer Res. 2021 Mar 1;27(5):1296-1304. doi: 10.1158/1078-0432.CCR-20-3136. Epub 2020 Dec 15.
Results Reference
derived
Learn more about this trial
Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone for First-line Treatment in Subjects With Programmed Death Ligand 1 (PD-L1) Positive Relapsed or Advanced Non-small Cell Lung Cancer (NSCLC)
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