mil60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of First-line mil60 Plus Paclitaxel/Carboplatin Versus Bevacizumab Plus Paclitaxel/Carboplatin in Patients With Advanced and Recurrent Non-squamous Non-small Cell Lung Cancer: a Randomized, Double-blind, Phase 3 Study

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: mil60
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mil60<br>mil60 (15mg/kg) was co-administered intravenously with 4 to 6-cycle paclitaxel/carboplatin, non-progressive patients are then given with maintenance single-agent mil60 (7.5mg/kg) until disease progression, intolerable toxicity, or withdrawal. | Drug: mil60<br>* 15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg<br>* Other names: No other intervention name;|
| Active Comparator: Bevacizumab<br>Bevacizumab (15mg/kg) was co-administered intravenously with 4 to 6-cycle paclitaxel/carboplatin, non-progressive patients are then given with maintenance single-agent mil60 (7.5mg/kg) until disease progression, intolerable toxicity, or withdrawal. | Drug: Bevacizumab<br>* 15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to mil60 at 7.5mg/kg<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Percentage of patients with complete remission or partial response | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Percentage of patients with complete remission or partial response | 26 months | 
| Duration of response | Interval from the onset of a complete remission or partial response until evidence of disease progression or death | 24 months | 
| Progression-free survival | Interval between randomization and disease progression or death | 24 months | 
| Disease control rate | Percentage of patients with complete remission, partial response and stable disease | 24 months | 
| Overall survival | the time from randomisation to death from any cause | 30 months |