To Compare Efficacy and Safety of CT-P16 and European Union-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Adenocarcinoma of Lung

Treatments: Drug: CT-P16; Drug: Avastin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03676192

CT-P16 3.1

Details and patient eligibility

About

To demonstrate that CT-P16 is similar to EU-Approved Avastin in terms of efficacy as determined by objective response rate (ORR) during the Induction Study Period

Enrollment: 689 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed as recurrent disease or stage IV
• has at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1

Exclusion criteria

• has predominantly squamous cell histology non-small cell lung cancer
• had surgery for metastatic non-squamous non-small cell lung cancer (nsNSCLC)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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689 participants in 2 patient groups

CT-P16

Experimental group

Description:

Drug: Bevacizumab 15mg/kg IV of CT-P16 will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until Progressive Disease (PD) or intolerable toxicity during the Maintenance Period.

Treatment:

Drug: CT-P16

Avastin

Active Comparator group

Description:

Drug: Bevacizumab 15mg/kg IV of EU-approved Avastin will be administered every 3 weeks up to 6 cycles during the Induction Study Period and every 3 weeks until PD or intolerable toxicity during the Maintenance Period.

Treatment:

Drug: Avastin