Description:
To demonstrate that CT-P16 is similar to US-approved Avastin in terms of efficacy determined by overall response rate (ORR) up to Cycle 6 during the Induction Study Period
To demonstrate that CT-P16 is similar to US-approved Avastin in terms of efficacy determined by overall response rate (ORR) up to Cycle 6 during the Induction Study Period
Active, not recruiting
Phase 3
Drug | Synonyms | Arms |
---|---|---|
CT-16 | CT-P16 | |
Avastin | Avastin |
Name | Type | Description | Interventions |
---|---|---|---|
CT-P16 | Experimental | Drug: Bevacizumab 15mg/kg IV of CT-16 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. |
|
Avastin | Active Comparator | 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. |
|
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 nsNSCLC
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Efficacy assessment: ORR |
Time Frame: | Primary efficacy endpoint-Induction Study Period (around 21 weeks) |
Safety Issue: | |
Description: | Objective Response Rate |
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Celltrion |
October 22, 2020