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Non-small Cell Lung CancerPhase 3NCT03196986

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

A Phase 3 study testing mil60 and Bevacizumab in people with Non-small Cell Lung Cancer, run by Beijing Mabworks Biotech Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
mil60 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
517 participants
Where
2 sitesChina
Study dates
15 Aug 2017to 30 Jul 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer Institute/Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Peking University Shenzhen Hospital

    Shenzhen

Other trials in China

About this study

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

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.

Read the 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.

Being tested
mil60, Bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mil60Drug

    Also called No other intervention name

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

  • BevacizumabDrug

    Also called Avastin

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

Study groups in NCT03196986
Study groupRoleWhat they receive
mil60Experimentalmil60 (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.
Receives: Drug: mil60
BevacizumabActive comparatorBevacizumab (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.
Receives: Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Percentage of patients with complete remission or partial response

    Measured: 24 months

Secondary outcomes (5)

  1. Objective response rate

    Percentage of patients with complete remission or partial response

    Measured: 26 months

  2. Duration of response

    Interval from the onset of a complete remission or partial response until evidence of disease progression or death

    Measured: 24 months

  3. Progression-free survival

    Interval between randomization and disease progression or death

    Measured: 24 months

  4. Disease control rate

    Percentage of patients with complete remission, partial response and stable disease

    Measured: 24 months

  5. Overall survival

    the time from randomisation to death from any cause

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2017
  2. Study start15 Aug 2017
  3. Primary completion1 Aug 2019
  4. Study completion30 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03196986
Sponsor's protocol ID
mil60-CT02
Status last verified
Jan 2023
First submitted
21 Jun 2017
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34841235

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mil60 and Bevacizumab in people with Non-small Cell Lung Cancer, run by Beijing Mabworks Biotech Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03196986, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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