Clinical Trials /

MIL60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer

NCT03196986

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
MIL60No other intervention nameMIL60
BevacizumabAvastinBevacizumab

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 chemotherapy-naive patients with metastatic or recurrent non-squamous NSCLC.

Trial Arms

NameTypeDescriptionInterventions
MIL60ExperimentalMIL60 (15mg/kg) was co-administered intravenously with 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.
  • MIL60
BevacizumabActive ComparatorBevacizumab (15mg/kg) was co-administered intravenously with 6-cycle paclitaxel/carboplatin, non-progressive patients are then given with maintenance single-agent bevacizumab (7.5mg/kg) until disease progression, intolerable toxicity, or withdrawal.
  • Bevacizumab

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 small cell carcinoma, or adenocarcinoma
             component

          -  Patients with EGFR mutation, or known ALK 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:18 months
Safety Issue:
Description:Percentage of patients with complete remission or partial response

Secondary Outcome Measures

Measure:Disease control rate
Time Frame:18 months
Safety Issue:
Description:Percentage of patients with complete remission, partial response, and stable disease
Measure:Progression-free survival
Time Frame:20 months
Safety Issue:
Description:Internal between randomization and disease progression or death

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Beijing Mabworks Biotech Co., Ltd.

Last Updated

November 6, 2017