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

Sponsor
Mylan Pharmaceuticals Inc
Study ID
NCT04633564
Phase
PHASE3
Status
Completed

Conditions

  • NSCLC Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Nov 18, 2020
Start date
Jan 21, 2017
Status verified
Mar 2022
Primary completion
Jun 5, 2019
Completion
Nov 22, 2019

Study Design

Enrollment
671 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MYL-1402O
    Patients will begin Period 1 receiving bevacizumab combination therapy (MYL-1402O15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as MYL-1402O ). In Period 2, eligible patients will continue to receive bevacizumab ( MYL- 1402O) every 3 weeks as monotherapy.
  • Active Comparator: Avastin
    Patients will begin Period 1 receiving bevacizumab combination therapy ( Avastin15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV) on Day 0 of Cycle 1 for up to 6 cycles of therapy. Each cycle will consist of 3 weeks (21 days ± 3 days) and a cycle will start with the administration of bevacizumab (as Avastin). In Period 2, eligible patients will continue to receive bevacizumab (Avastin) every 3 weeks as monotherapy.

Primary Outcome Measure

Primary Efficacy Analysis of Overall Response Rate ( ORR) of MYL-1402O as Compared to Avastin [ Time Frame: 18 weeks after first dosing per patient ]

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