Adenocarcinoma of LungPhase 3NCT03676192

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

A Phase 3 study testing CT-P16 and Avastin in people with Adenocarcinoma of Lung, run by Celltrion at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adenocarcinoma of Lung
What is being tested?: CT-P16 and Avastin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 689 participants
Where: 1 siteSouth Korea
Study dates: 1 Feb 2019to 19 Sep 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chung-Ang University Hospital
Seoul, 06973

Other trials in South Korea

About this study

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

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

Conditions: Adenocarcinoma of Lung
Being tested: CT-P16, Avastin
Medical subject headings: Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P16Drug
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.
AvastinDrug
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.

Study groups in NCT03676192
Study group	Role	What they receive
CT-P16	Experimental	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. Receives: Drug: CT-P16
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. Receives: Drug: Avastin

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR) During the Induction Study Period From Central Review
The ORR was defined as the proportion of patients with a confirmed Best Overall Response (BOR) of CR or PR (the 'responder'). All other patients except responders were considered as non-responders, including patients without post-baseline tumor assessment.
Measured: Induction Study Period (around 18 weeks)

Secondary outcomes (6)

Response Duration From Central Review
Response duration was defined as time between initial response (CR or PR) that is confirmed by the subsequent assessment after study treatment administration and PD/recurrence or death from any cause, whichever occurs first.
Measured: Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.
Time to Progression From Central Review
Time to progression was defined as time from randomization to determined PD/recurrence.
Measured: Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.
Progression Free Survival From Central Review
Progression-free survival was defined as time from randomization to determined PD/recurrence or death from any cause, whichever occurs first.
Measured: Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.
Overall Survival
Overall survival was defined as time from randomization to death from any cause.
Measured: Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.
Trough Serum Concentrations During the Induction Study Period
Pharmacokinetic samples were collected on Day 1 of each cycle (prior to the beginning of the study drug administration) in the Induction Study Period.
Measured: Induction Study Period. Pharmacokinetic samples were collected on Day 1 of each cycle in Induction Study Period.
Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period
Immunogenicity was assessed on Day 1 of Cycle 1 (pre-dose), every 2 cycles during the Induction Study Period, and every 3 cycles during the Maintenance Study Period and End of Treatment (EOT) visit. In the Follow-Up Period, immunogenicity was assessed once at the first visit of the Follow-Up Period (ninth week).
Measured: Immunogenicity was assessed Day 1 of Cycle 1 (predose), every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, EOT visit, and at the first visit of Follow-up period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201919 Sep 2023

First posted18 Sep 2018
Study start1 Feb 2019
Primary completion22 Apr 2021
Study completion19 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Adenocarcinoma of LungStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 689 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03676192
Sponsor's protocol ID: CT-P16 3.1
Status last verified: Feb 2025
First submitted: 6 Sep 2018
Last updated: 17 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kim T, Kim H, Lee H, Ahn K, Park T, Baek H, Chang MJ. Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin(R) and US-Avastin(R) in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. BioDrugs. 2026 Aug 2. doi: 10.1007/s40259-026-00800-1. Online ahead of print.
PubMed 42542998
Andric Z, Moiseenko F, Makharadze T, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Ju H, Baek EH, Kwon S, Chang I, Kim S, Kim H, Lee E, Verschraegen C. Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer. Cancer Treat Res Commun. 2025;44:100970. doi: 10.1016/j.ctarc.2025.100970. Epub 2025 Jul 24.
PubMed 40795416
Verschraegen C, Andric Z, Moiseenko F, Makharadze T, Shevnya S, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Park S, Ju H, Ohe Y. Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial. BioDrugs. 2022 Nov;36(6):749-760. doi: 10.1007/s40259-022-00552-8. Epub 2022 Sep 28.
PubMed 36169807

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adenocarcinoma of Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03676192
Acronym / sponsor ID: CT-P16 3.1
Conditions: Adenocarcinoma of Lung
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 689 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 1 Feb 2019 (actual)
Primary completion: 22 Apr 2021 (actual)
Study completion: 19 Sep 2023 (actual)
First posted: 18 Sep 2018 (actual)
Results: Posted 17 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CT-P16	Experimental	Drug: CT-P16Drug: 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.
Avastin	Active comparator	Drug: AvastinDrug: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P1615mg/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.	Drug	CT-P16
Avastin15mg/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.	Drug	Avastin

Primary outcome

Objective Response Rate (ORR) During the Induction Study Period From Central Review
Time frame: Induction Study Period (around 18 weeks)
The ORR was defined as the proportion of patients with a confirmed Best Overall Response (BOR) of CR or PR (the 'responder'). All other patients except responders were considered as non-responders, including patients without post-baseline tumor assessment.

6 secondary outcomes

Response Duration From Central Review
Time frame: Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.
Time to Progression From Central Review
Time frame: Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.
Progression Free Survival From Central Review
Time frame: Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.
Overall Survival
Time frame: Tumor assessments were assessed every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, and at the EOT visit. The median follow-up time from randomization was 12.86 months.
Trough Serum Concentrations During the Induction Study Period
Time frame: Induction Study Period. Pharmacokinetic samples were collected on Day 1 of each cycle in Induction Study Period.
Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period
Time frame: Immunogenicity was assessed Day 1 of Cycle 1 (predose), every 2 cycles during the Induction Study Period, every 3 cycles during the Maintenance Study Period, EOT visit, and at the first visit of Follow-up period.

Results and safety

Results posted to the registry on 17 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Avastin	347	241
CT-P16	342	258

Primary outcome: Objective Response Rate (ORR) During the Induction Study Period From Central Review

Time frame: Induction Study Period (around 18 weeks). Number (95% Confidence Interval). Unit: percentage of responders

Measure	CT-P16 n = 342	Avastin n = 347
Value	42.40 (37.16 to 47.64)	42.07 (36.88 to 47.27)

CT-P16 vs Avastin: Risk Difference (RD): 0.40 (95% CI -7.02 to 7.83)
CT-P16 vs Avastin: Risk Ratio (RR): 1.0136 (90% CI 0.8767 to 1.1719)

Population analysed: Intent-to-Treat (ITT) population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the date the informed consent form is signed until up to 28 days from last dose of study drug, regardless of the relationship to the study drug, regardless of the relationship to the study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P16	69 of 345 (20%)	332 of 345 (96.2%)	24 of 345
Avastin	73 of 344 (21.2%)	320 of 344 (93%)	25 of 344

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42542998Kim T, Kim H, Lee H, Ahn K, Park T, Baek H, Chang MJ. Population Pharmacokinetic Comparability of CT-P16 Versus EU-Avastin(R) and US-Avastin(R) in Healthy Subjects and Patients with Non-Squamous Non-Small Cell Lung Cancer. BioDrugs. 2026 Aug 2. doi: 10.1007/s40259-026-00800-1. Online ahead of print.
Derived from this study: PubMed 40795416Andric Z, Moiseenko F, Makharadze T, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Ju H, Baek EH, Kwon S, Chang I, Kim S, Kim H, Lee E, Verschraegen C. Long-term results of a randomized controlled trial of biosimilar CT-P16 and reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer. Cancer Treat Res Commun. 2025;44:100970. doi: 10.1016/j.ctarc.2025.100970. Epub 2025 Jul 24.
Derived from this study: PubMed 36169807Verschraegen C, Andric Z, Moiseenko F, Makharadze T, Shevnya S, Oleksiienko A, Yanez Ruiz E, Kim S, Ahn K, Park T, Park S, Ju H, Ohe Y. Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial. BioDrugs. 2022 Nov;36(6):749-760. doi: 10.1007/s40259-022-00552-8. Epub 2022 Sep 28.

Related trials for Adenocarcinoma of Lung

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CT-P16 and Avastin in people with Adenocarcinoma of Lung, run by Celltrion at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) During the Induction Study Period From Central Review (time frame: Induction Study Period (around 18 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03676192, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.