Trial · NCT03676192
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
NCT03676192, Phase 3, Completed, Celltrion; results first posted 2025-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03676192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03676192
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT03676192
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 689 participants, actual
- Lead sponsor
- Celltrion
- Conditions
- Adenocarcinoma of Lung
- Interventions
- CT-P16, Avastin
- First posted
- 2018-09-18
- Last updated
- 2025-03-17
- Results first posted
- 2025-03-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) During the Induction Study Period From Central Review | 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. |
| Secondary | Response Duration From Central Review | 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. | 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. |
| Secondary | Time to Progression From Central Review | 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 was defined as time from randomization to determined PD/recurrence. |
| Secondary | Progression Free Survival From Central Review | 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 was defined as time from randomization to determined PD/recurrence or death from any cause, whichever occurs first. |
| Secondary | Overall Survival | 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 was defined as time from randomization to death from any cause. |
| Secondary | Trough Serum Concentrations During the Induction Study Period | Induction Study Period. Pharmacokinetic samples were collected on Day 1 of each cycle in 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. |
| Secondary | Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period | 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. | 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). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) During the Induction Study Period From Central Review | Induction Study Period (around 18 weeks) | 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. | percentage of responders | NUMBER |
| SECONDARY | Response Duration From Central Review | 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. | Patients who have confirmed BOR of CR or PR from ITT population (All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed). | Proportion of participants | NUMBER |
| SECONDARY | Time to Progression From Central Review | 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. | ITT population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. | Proportion of participants | NUMBER |
| SECONDARY | Progression Free Survival From Central Review | 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. | ITT population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. | Proportion of participants | NUMBER |
| SECONDARY | Overall Survival | 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. | ITT population: All randomized patients who were randomly assigned to study drug regardless of whether or not any study treatment dosing was completed. | Proportion of participants | NUMBER |
| SECONDARY | Trough Serum Concentrations During the Induction Study Period | Induction Study Period. Pharmacokinetic samples were collected on Day 1 of each cycle in Induction Study Period. | Pharmacokinetic (PK) population: all randomly assigned patients who received at least 1 full dose of study drug (CT-P16 or Avastin) and who had at least 1 post-treatment PK result. Patients who received incorrect treatment during the Induction Study Period were excluded from the PK population. | μg/L | MEAN |
| SECONDARY | Patients With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) at Anytime During the Whole Study Period | 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. | Safety Population: all randomly assigned patients who received at least 1 dose (partial or full) of study drug (CT-P16 or Avastin). Patients receiving at least 1 dose of CT-P16 at any time of during the treatment period were analyzed under the CT-P16 treatment group. Three patients who were randomized to Avastin treatment group were analyzed under the CT-P16 treatment group since the patients incorrectly received CT-P16 during the treatment period. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) During the Induction Study Period From Central Review | CT-P16 | 42.40 | 95% Confidence Interval 37.16 to 47.64 | percentage of responders | |
| Objective Response Rate (ORR) During the Induction Study Period From Central Review | Avastin | 42.07 | 95% Confidence Interval 36.88 to 47.27 | percentage of responders | |
| Response Duration From Central Review | CT-P16 | 6 months | 0.60 | 95% Confidence Interval 0.51 to 0.67 | Proportion of participants |
| Response Duration From Central Review | Avastin | 6 months | 0.56 | 95% Confidence Interval 0.48 to 0.64 | Proportion of participants |
| Response Duration From Central Review | CT-P16 | 12 months | 0.17 | 95% Confidence Interval 0.11 to 0.25 | Proportion of participants |
| Response Duration From Central Review | Avastin | 12 months | 0.25 | 95% Confidence Interval 0.18 to 0.32 | Proportion of participants |
| Response Duration From Central Review | CT-P16 | 24 months | 0.09 | 95% Confidence Interval 0.04 to 0.15 | Proportion of participants |
| Response Duration From Central Review | Avastin | 24 months | 0.10 | 95% Confidence Interval 0.06 to 0.17 | Proportion of participants |
| Response Duration From Central Review | CT-P16 | 36 months | 0.08 | 95% Confidence Interval 0.04 to 0.14 | Proportion of participants |
| Response Duration From Central Review | Avastin | 36 months | 0.06 | 95% Confidence Interval 0.02 to 0.12 | Proportion of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Study Period | STARTED | Avastin | 347 | |
| Induction Study Period | STARTED | CT-P16 | 342 | |
| Induction Study Period | COMPLETED | Avastin | 241 | |
| Induction Study Period | COMPLETED | CT-P16 | 258 | |
| Induction Study Period | NOT COMPLETED | Avastin | 106 | |
| Induction Study Period | NOT COMPLETED | CT-P16 | 84 | |
| Maintenance Study Period | STARTED | Avastin | 227 | |
| Maintenance Study Period | STARTED | CT-P16 | 239 | |
| Maintenance Study Period | COMPLETED | Avastin | 227 | |
| Maintenance Study Period | COMPLETED | CT-P16 | 239 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events272
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | CT-P16 | 109 | 345 | |
| other | Anaemia | Blood and lymphatic system disorders | Avastin | 93 | 344 | |
| other | Leukopenia | Blood and lymphatic system disorders | CT-P16 | 30 | 345 | |
| other | Leukopenia | Blood and lymphatic system disorders | Avastin | 23 | 344 | |
| other | Neutropenia | Blood and lymphatic system disorders | CT-P16 | 75 | 345 | |
| other | Neutropenia | Blood and lymphatic system disorders | Avastin | 55 | 344 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CT-P16 | 63 | 345 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Avastin | 48 | 344 | |
| other | Constipation | Gastrointestinal disorders | CT-P16 | 38 | 345 | |
| other | Constipation | Gastrointestinal disorders | Avastin | 33 | 344 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CT-P16 | 24 | 345 |
| Total, all-cause mortality | Avastin | 25 | 344 |
| Total, other adverse events | CT-P16 | 332 | 345 |
| Total, other adverse events | Avastin | 320 | 344 |
| Total, serious adverse events | CT-P16 | 69 | 345 |
| Total, serious adverse events | Avastin | 73 | 344 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CT-P16 vs Avastin: deaths from any cause | Trial comparisons |
| CT-P16 vs Avastin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03676192
GET https://conductscience.org/api/trials/v1/NCT03676192/results?page=2