NCT03196986

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

June 21, 2017

Last Update Submit

January 28, 2023

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Percentage of patients with complete remission or partial response

    24 months

Secondary Outcomes (5)

  • Objective response rate

    26 months

  • Duration of response

    24 months

  • Progression-free survival

    24 months

  • Disease control rate

    24 months

  • Overall survival

    30 months

Study Arms (2)

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.

Drug: mil60

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.

Drug: Bevacizumab

Interventions

mil60DRUG

15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg

Also known as: No other intervention name
mil60
BevacizumabDRUG

15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to mil60 at 7.5mg/kg

Also known as: Avastin
Bevacizumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer Institute/Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Peking University Shenzhen Hospital

Shenzhen, China

Location

Related Publications (1)

  • Wan R, Dong X, Chen Q, Yu Y, Yang S, Zhang X, Zhang G, Pan Y, Sun S, Zhou C, Hong W, Zhao H, Yang L, Huang L, Wu R, Zang A, Ma R, Wu L, Lv D, Fu X, Han J, Li W, Duan J, Wang K, Jiang O, Chen Y, Guo Z, Gao H, Wen J, Wang S, Zhao E, Li G, Yue L, Liang L, Zeng A, Wang X, Zhu Y, Pan H, Dai Z, Feng W, Zhao G, Lin C, Li C, Li N, Bao Y, Li Y, Su Y, Zhao M, Fang H, Zhu Y, Zhang Y, Ding L, Wang Y, Yuan X, Wang J. Efficacy and safety of MIL60 compared with bevacizumab in advanced or recurrent non-squamous non-small cell lung cancer: a phase 3 randomized, double-blind study. EClinicalMedicine. 2021 Nov 19;42:101187. doi: 10.1016/j.eclinm.2021.101187. eCollection 2021 Dec.

    PMID: 34841235DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jie Wang, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 23, 2017

Study Start

August 15, 2017

Primary Completion

August 1, 2019

Study Completion

July 30, 2021

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)