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MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC

NCT04633564 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2022-03-16

Study results available
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Summary

Assess the Efficacy and Safety of MYL-1402O Compared with Avastin®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer

Conditions

  • NSCLC Stage IV

Interventions

BIOLOGICAL

Bevacizumab as MYL-1402O

Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV

BIOLOGICAL

Bevacizumab as Avastin

Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Tazeen A Idris, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-21
Primary Completion
2019-06-05
Completion
2019-11-22

Countries

  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Georgia
  • Hungary
  • India
  • Italy
  • Philippines
  • Poland
  • Romania
  • Russia
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633564 on ClinicalTrials.gov