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

Non-small Cell Lung Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT03196986
• Other study ID #: mil60-CT02
• Status: Completed
• Phase: Phase 3
• Start date: August 15, 2017
• Est. completion date: July 30, 2021

Study information

• Verified date: January 2023
• Source: Beijing Mabworks Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: July 30, 2021
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• mil60
15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg
• Bevacizumab
15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to mil60 at 7.5mg/kg

Locations

Country	Name	City	State
China	Cancer Institute/Hospital, Chinese Academy of Medical Sciences	Beijing
China	Peking University Shenzhen Hospital	Shenzhen

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Mabworks Biotech Co., Ltd.	Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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