To Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT03676192 |
Recruitment Status :
Active, not recruiting
First Posted : September 18, 2018
Last Update Posted : August 26, 2022
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Condition or disease | Intervention/treatment | Phase |
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Adenocarcinoma of Lung | Drug: CT-16 Drug: Avastin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 689 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer |
Actual Study Start Date : | December 19, 2018 |
Actual Primary Completion Date : | April 22, 2021 |
Estimated Study Completion Date : | August 2023 |

Arm | Intervention/treatment |
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Experimental: CT-P16
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.
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Drug: CT-16
15mg/kg IV of CT-P16 every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
Active Comparator: Avastin
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.
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Drug: Avastin
15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period. |
- Efficacy assessment: ORR [ Time Frame: Primary efficacy endpoint-Induction Study Period (around 21 weeks) ]Objective Response Rate

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676192
Korea, Republic of | |
Chung-Ang University Hospital | |
Seoul, Korea, Republic of, 06973 |
Responsible Party: | Celltrion |
ClinicalTrials.gov Identifier: | NCT03676192 |
Other Study ID Numbers: |
CT-P16 3.1 |
First Posted: | September 18, 2018 Key Record Dates |
Last Update Posted: | August 26, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adenocarcinoma of Lung Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |