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

NCT ID: NCT03196986

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 517 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2021-07-30

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.

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

mil60

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

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

Interventions

mil60

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

Intervention Type: DRUG

Bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

No other intervention name; Avastin

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Institute/Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Peking University Shenzhen Hospital

Shenzhen, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34841235 (View on PubMed)

Other Identifiers

mil60-CT02

Identifier Type: -

Identifier Source: org_study_id