Non-small Cell Lung Cancer
Conditions
Brief summary
This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in treatment-naive patients with advanced or recurrent non-squamous NSCLC.
Detailed description
This is a multicenter, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of mil60 plus paclitaxel and carboplatin versus bevacizumab plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.The primary objective of the study was to compare the Objective Response Rate according to RECIST 1.1 of mil60 in combination with paclitaxel plus carboplatin and bevacizumab plus paclitaxel plus carboplatin in the treatment of advanced or recurrent non-squamous NSCLC subjects.
Interventions
DRUGmil60
15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg
DRUGBevacizumab
15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to mil60 at 7.5mg/kg
Sponsors
Betta Pharmaceuticals Co., Ltd.
Beijing Mabworks Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* signed inform consent form(ICF) * Aged 18-75 years, male or female * Histologically or cytologically documented inoperable, local advanced (stage IIIB), metastatic (stage IV), or recurrent non-squamous NSCLC * At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1 * Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1 * Life expectancy ≥ 12 weeks * Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for 6 months after receiving last study treatment
Exclusion criteria
* Mixed non-small cell lung cancer with squamous cell carcinoma component, or small cell carcinoma * Patients with known Anaplastic Lymphoma Kinase（ALK） or C-Ros Oncogene 1 Receptor Tyrosine Kinase （ROS1）rearrangement * History of hemoptysis within 3 months prior to screening with blood volume more than 2.5 mL * Evidence of tumor invading major blood vessels on imaging * Patients with brain metastasis, spinal cord compression or carcinomatous meningitis history * Uncontrolled hypertension, prior history of hypertensive crisis and hypertensive encephalopathy * Clinically significant cardiovascular disease but not limited to active infections; unstable angina; stroke or transient cerebral ischemia; myocardial infarction; congestive heart-failure; serious cardiac arrhythmia, hepatic, renal or metabolic disease requiring medication during the study * History of radical radiotherapy to the thorax within 6 months * Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of the study * Recent or current treatment with aspirin or other non-steroidal anti-inflammatory drugs (NSAID) known to inhibit platelet function within 10 days prior to first dose of study treatment * Recent or current treatment with anticoagulants or thrombolytic agent within 10 days prior to first dose of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 24 months | Percentage of patients with complete remission or partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 26 months | Percentage of patients with complete remission or partial response |
| Duration of response | 24 months | Interval from the onset of a complete remission or partial response until evidence of disease progression or death |
| Progression-free survival | 24 months | Interval between randomization and disease progression or death |
| Disease control rate | 24 months | Percentage of patients with complete remission, partial response and stable disease |
| Overall survival | 30 months | the time from randomisation to death from any cause |
Countries
China
Outcome results
None listed