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

January 28, 2023 updated by: Beijing Mabworks Biotech Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
517

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Cancer Institute/Hospital, Chinese Academy of Medical Sciences
      • Shenzhen, China
        • Peking University Shenzhen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mil60
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
15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg
Other Names:
  • No other intervention name
Active Comparator: Bevacizumab
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
15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to mil60 at 7.5mg/kg
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 24 months
Percentage of patients with complete remission or partial response
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 26 months
Percentage of patients with complete remission or partial response
26 months
Duration of response
Time Frame: 24 months
Interval from the onset of a complete remission or partial response until evidence of disease progression or death
24 months
Progression-free survival
Time Frame: 24 months
Interval between randomization and disease progression or death
24 months
Disease control rate
Time Frame: 24 months
Percentage of patients with complete remission, partial response and stable disease
24 months
Overall survival
Time Frame: 30 months
the time from randomisation to death from any cause
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Mabworks Biotech Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Betta Pharmaceuticals Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jie Wang, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • mil60-CT02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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