A Phase III study to compare the safety and efficacy of Bevacizumab against Avastinâ?¢ in Patients with Non-Small Cell Lung Cancer

A Prospective, Comparative, Open Label, Randomized, Multicentric, Phase III study to compare the safety and efficacy of Bevacizumab of Intas Pharmaceuticals Limited against Avastinâ?¢ in Patients with Unresectable or Metastatic Non-Squamous Non-Small Cell Lung Cancer - NA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/09/005042

Enrollment

129

Registered

2014-09-22

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- Unresectable or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Interventions

Intervention1: Bevacizumab_Intas: Bevacizumab will be administered initially as a 90-minute IV infusion every 21 days cycle, Duration: 4 cycles(84 days) Control Intervention1: Avastinâ?¢_Roche: Avasti

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient of both sex aged 18-65 years (both inclusive). 2.Patient suffering from histologically or cytologically confirmed non-small cell lung cancer EXCEPT squamous cell carcinoma. 3.Patients with advanced, unresectable or metastatic NSCLC suitable for treatment with bevacizumab combination therapy. 4.At-least one measurable lesion according to RECIST 1.1 criteria. 5.Eastern Cooperative Oncology Group (ECOG) performance status 6.Patients with adequate haematopoietic, liver and renal function 7.Women of childbearing potential agreed to use an accepted and effective method of contraception 8.Patients able to understand the investigational nature of this study and give written informed consent prior to the participation in the trial. 9.Able to comply with study requirement in opinion of Principal Investigator.

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating women. 2.Patients with clinically significant cardiac diseases. 3.Uncontrolled hypertension 4.Patient with ongoing or active infection(s). 5.History of thrombotic events like stroke, active symptomatic peripheral vasculardisease 6.Known hypersensitivity to any components of the study medications and ingredients 7.Any other medical conditions(including mental illness, substance abuse, social situations) deemed by the clinician

Design outcomes

Primary

Measure	Time frame
To demonstrate therapeutic equivalence between bevacizumab of Intas and Avastinâ?¢ of Roche in adult patients with unresectable or metastatic non-squamous non-small cell carcinoma of lung.Timepoint: At the end of study	—

Secondary

Measure	Time frame
â?¢To demonstrate the safety and tolerability of both products â?¢To compare the pharmacokinetics of bevacizumab of Intas and Avastinâ?¢ of RocheTimepoint: â?¢Throughout whole study â?¢Pre-dose ,Post-dose: 0.333, 0.667, 1.000, 1.250, 1.500, 1.750, 2.000, 3.000, 6.000, 8.000, 12.000, 16.000, 24.000 , 48.000, 96.000, 168.000, 312.000 and 480.000 hours post-dose	—

Countries

India

Contacts

Public ContactHarshit Shah

Lambda Therapeutic Research Ltd

arpitkprajapati@lambda-cro.com07940202322

Outcome results

None listed

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