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
Overview
- Phase
- Phase 3
- Intervention
- Camrelizumab 200mg
- Conditions
- PD-L1 Positive Non-small Cell Lung Cancer
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 762
- Primary Endpoint
- Progression Free Survival (PFS) assessed by Independent review committee (IRC)
- Last Updated
- 5 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Camrelizumab 200mg + Apatinib Mesylate 250mg
Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
Intervention: Camrelizumab 200mg
Pemetrexed/Paclitaxel injection+ Carboplatin
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
Intervention: Carboplatin
Camrelizumab 200mg + Apatinib Mesylate 250mg
Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
Intervention: Apatinib Mesylate 250mg
Camrelizumab 200mg
Camrelizumab 200mg q2w ivgtt
Intervention: Camrelizumab 200mg
Pemetrexed/Paclitaxel injection+ Carboplatin
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
Intervention: Pemetrexed disodium for injection
Pemetrexed/Paclitaxel injection+ Carboplatin
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
Intervention: Paclitaxel injection
Outcomes
Primary Outcomes
Progression Free Survival (PFS) assessed by Independent review committee (IRC)
Time Frame: up to 2 years
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
Time Frame: up to 2 years
Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up
Secondary Outcomes
- Time to Treatment Failure(Up to 2 years)
- Disease Control Rate(At the time point of every 6 weeks，up to 2 years)
- Adverse Events and Serious Adverse Events(from the first drug administration to within 90 days for the last Camrelizumab dose)
- PFS assessed by investigator(up to 2 years)
- Objective Response Rate(At the time point of every 6 weeks，up to 2 years)
- Duration of Response(Up to 2 years)