A Randomized, Double-blind, Multicentric, Parallel-group Study Comparing Efficacy, Safety and Immunogenicity of CBT124, a Candidate Biosimilar Bevacizumab in Combination with Carboplatin and Paclitaxel with EU sourced Avastin® in Combination with Carboplatin and Paclitaxel in First line Treatment for Subjects with Stage IV (Unresectable Recurrent Disease or Metastatic) Non-squamous Non-Small Cell Lung Cancer (NSCLC) - Efficacy, Safety & Immunogenicity Study of CBT124 & EU-sourced Avastin®

Cipla BioTec Pvt. Ltd.0 sites200 target enrollmentOctober 5, 2016

Overview

No summary available.

Registry

who.int

Start Date

October 5, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Cipla BioTec Pvt. Ltd.

•Adult subjects aged \= 18 to 75 years (\= 18 to 65 years for India) with histologically or cytologically confirmed advanced non\-squamous NSCLC.
•Epidermal growth factor receptor (EGFR) negative or wild type
•Stage IV (Unresectable recurrent disease or metastatic) NSCLC
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\.
•Evaluable disease status or measurable tumor
•Adequate hepatic, renal, and bone marrow function
•Subjects with pre\-existing hypertension must be well controlled on a stable regimen of antihypertensive therapy. Have systolic blood pressure \= 140 and \= 90 mmHg, diastolic blood pressure \= 90 and \= 50 mmHg and heart rate \= 40 and \= 90 bpm at screening and admission.
•Ability to understand risks of participation in the study and willingness provide informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•Small cell lung cancer (SCLC) or combination of SCLC and NSCLC.
•Squamous\-cell tumors and mixed adenosquamous carcinomas of
•predominantly squamous nature
•Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including bevacizumab
•Prior therapy with carboplatin or paclitaxel
•Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or radiotherapy for locally\-advanced NSCLC if completed \<12 months prior to screening
•Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that in the opinion of the Investigator is likely to bleed
•Symptomatic brain metastasis
•Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of the skin or pre\-invasive cancer of the cervix
•Any unresolved toxicity \> Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)