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

Phase 3

• Conditions: Health Condition 1: null- Unresectable or Metastatic Non-Squamous Non-Small Cell Lung Cancer

• Registration Number: CTRI/2014/09/005042
• Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 129

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 <=2.

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate therapeutic equivalence between bevacizumab of Intas and Avastinâ?¢ of Roche in adult patients with unresectable or <br/ ><br>metastatic non-squamous non-small cell carcinoma of lung.Timepoint: At the end of study

Secondary Outcome Measures

Name	Time	Method
â?¢To demonstrate the safety and tolerability of both products <br/ ><br>â?¢To compare the pharmacokinetics of bevacizumab of Intas and Avastinâ?¢ of RocheTimepoint: â?¢Throughout whole study <br/ ><br>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