A clinical trial intended to assess the Efficacy and Safety of MYL-1402O Compared With AvastinÂ®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer

Multicenter, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of MYL-1402O Compared With AvastinÂ®, in the First-line Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/12/007557

Enrollment

650

Registered

2016-12-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Non-Squamous Non-Small Cell Lung Cancer

Interventions

Intervention1: Bevacizumab (MYL 1402O): Single intravenous infusion (15 mg/kg) every 21 days with infusion between 30-90 minutes. Treatment duration: 52Weeks Control Intervention1: Avastin: Single int

Eligibility

Inclusion criteria

Inclusion criteria: 1.Has demonstrated the ability to understand verbal and/or written instructions, to provide written informed consent, and is capable and agreeable to comply with protocol requirements. 2.Male or female at least 18 years of age at the time of signing an informed consent form (ICF). 3.Has a documented imaging diagnosis of Stage IV unresectable, recurrent or metastatic nsNSCLC. 4.Has measurable disease with at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) 5.Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. 6.Has at least 6 months of expected survival.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
To compare the ORR of MYL-1402O compared with Avastin in combination with a carboplatin and paclitaxel (CP) chemotherapy treatment of unresectable, recurrent or metastatic Stage IV nsNSCLCTimepoint: At 18 weeks	—

Secondary

Measure	Time frame
â?? To assess the safety profile of MYL-1402O â?? To assess Disease Control Rate at 18 weeks, CR, PR or SD â?? To assess time-to-event endpoints: median PFS and OS â?? To assess the potential immunogenicity (detection of anitbodies to bevacizumab) â?? To compare the PK profile using a population PK approach Timepoint: At 18 weeks and end of study	—

Countries

Argentina, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Croatia, Georgia, Hungary, India, Indonesia, Italy, Malaysia, Philippines, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, Ukraine, Viet Nam

Contacts

Public ContactMs Aarti Sareen

Cliantha Research Limited

abarnwal@cliantha.com919909019497

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026