Description:
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.
Title
- Brief Title: MIL60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
MIL60-CT02
- NCT ID:
NCT03196986
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
MIL60 | No other intervention name | MIL60 |
Bevacizumab | Avastin | Bevacizumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
MIL60 | Experimental | 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. | |
Bevacizumab | Active Comparator | 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. | |
Eligibility Criteria
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 ALK or 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
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Percentage of patients with complete remission or partial response |
Secondary Outcome Measures
Measure: | Objective response rate |
Time Frame: | 26 months |
Safety Issue: | |
Description: | Percentage of patients with complete remission or partial response |
Measure: | Duration of response |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Interval from the onset of a complete remission or partial response until evidence of disease progression or death |
Measure: | Progression-free survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Interval between randomization and disease progression or death |
Measure: | Disease control rate |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Percentage of patients with complete remission, partial response and stable disease |
Measure: | Overall survival |
Time Frame: | 30 months |
Safety Issue: | |
Description: | the time from randomisation to death from any cause |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Beijing Mabworks Biotech Co., Ltd. |
Last Updated
October 4, 2019