Trial · NCT03296163
A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT03296163, Phase 3, Completed, mAbxience Research S.L.; results first posted 2021-03-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT03296163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03296163
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT03296163
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 627 participants, actual
- Lead sponsor
- mAbxience Research S.L.
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- MB02 (Bevacizumab Biosimilar Drug), EU-approved Avastin®, Carboplatin, Paclitaxel
- First posted
- 2017-09-28
- Last updated
- 2021-04-26
- Results first posted
- 2021-03-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) at Week 18 | 18 weeks from randomisation | Objective response rate was assigned for a subject if the subject displayed either complete response (CR) or partial response (PR) per RECIST version 1.1 at Week 18, as assessed by independent radiological review committee (IRC). Overall Response (OR) = CR + PR. |
| Secondary | Progression-free Survival (PFS) | At Week 52 from randomisation | Progression-free survival was defined as the time from randomization to subsequent confirmed progression per RECIST version 1.1, or death (whichever occurred first), measured in weeks and months. For PFS assessment clinical progression (i.e., treatment discontinuation due to progression of disease) was also considered as an event. |
| Secondary | Overall Survival (OS) | At Week 52 from randomisation | Overall survival was defined as the time from randomization to subsequent death, measured in weeks and months. |
| Secondary | Incidence of Treatment-emergent Adverse Events (TEAEs) | Week 1 to week 52 | Comparison of Safety profile. Safety was monitored by incidence of adverse events (AEs). AEs were coded as per MedDRA (version 20.1) and severity was graded according to NCI-CTCAE (version 4.03); |
| Secondary | Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb]) | At Weeks 1, 4, 10, 19, 34 and 52 from randomization and, at the End of Treatment Visit if, an ADA sample has not been collected within the previous 3 weeks | Incidence of anti-drug antibodies (ADA) and neutralizing ADAs (NAb). Analyses of ADA incidence rate, antibody titer, and neutralizing antibodies (NAb) (following the recommended 3-tier approach) were performed. |
Source ClinicalTrials.gov
Outcomes5
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) at Week 18 | 18 weeks from randomisation | Primary efficacy analysis was done in the intention-to-treat (ITT) population. | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | At Week 52 from randomisation | weeks | MEDIAN | |
| SECONDARY | Overall Survival (OS) | At Week 52 from randomisation | weeks | MEDIAN | |
| SECONDARY | Incidence of Treatment-emergent Adverse Events (TEAEs) | Week 1 to week 52 | Safety analyses were performed in the Safety population, which consisted of all subjects who received at least 1 administration of investigational medicinal product. | participants | NUMBER |
| SECONDARY | Immunogenicity Assessments (Anti-drug Antibodies [ADA] and Neutralizing Antibodies [NAb]) | At Weeks 1, 4, 10, 19, 34 and 52 from randomization and, at the End of Treatment Visit if, an ADA sample has not been collected within the previous 3 weeks | Immunogenicity was assessed in the Safety population. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
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) at Week 18 | MB02 (Bevacizumab Biosimilar Drug) | 40.3 | 95% Confidence Interval 34.9 to 46.0 | Percentage of participants | |
| Objective Response Rate (ORR) at Week 18 | EU-approved Avastin® | 44.6 | 95% Confidence Interval 39.0 to 50.3 | Percentage of participants | |
| Progression-free Survival (PFS) | MB02 (Bevacizumab Biosimilar Drug) | 36.0 | 95% Confidence Interval 33.0 to 36.43 | weeks | |
| Progression-free Survival (PFS) | EU-approved Avastin® | 37.3 | 95% Confidence Interval 36.14 to 45.14 | weeks | |
| Overall Survival (OS) | MB02 (Bevacizumab Biosimilar Drug) | NA | 95% Confidence Interval NA to NA | weeks | |
| Overall Survival (OS) | EU-approved Avastin® | NA | 95% Confidence Interval NA to NA | weeks | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | MB02 (Bevacizumab Biosimilar Drug) | with ≥1 TEAE | 288 | participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | EU-approved Avastin® | with ≥1 TEAE | 288 | participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | MB02 (Bevacizumab Biosimilar Drug) | with ≥1 Grade 3 or 4 TEAE | 131 | participants | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | EU-approved Avastin® | with ≥1 Grade 3 or 4 TEAE | 125 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Combination Therapy | STARTED | MB02 (Bevacizumab Biosimilar Drug) | 315 | |
| Combination Therapy | STARTED | EU-approved Avastin® | 312 | |
| Combination Therapy | COMPLETED | MB02 (Bevacizumab Biosimilar Drug) | 207 | |
| Combination Therapy | COMPLETED | EU-approved Avastin® | 220 | |
| Combination Therapy | NOT COMPLETED | MB02 (Bevacizumab Biosimilar Drug) | 108 | |
| Combination Therapy | NOT COMPLETED | EU-approved Avastin® | 92 | |
| Monotherapy | STARTED | MB02 (Bevacizumab Biosimilar Drug) | 207 | |
| Monotherapy | STARTED | EU-approved Avastin® | 220 | |
| Monotherapy | COMPLETED | MB02 (Bevacizumab Biosimilar Drug) | 68 | |
| Monotherapy | COMPLETED | EU-approved Avastin® | 74 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events232
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 | Alopecia | Skin and subcutaneous tissue disorders | MB02 (Bevacizumab Biosimilar Drug) | 155 | 311 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | EU-approved Avastin® | 163 | 310 | |
| other | Anemia | Blood and lymphatic system disorders | MB02 (Bevacizumab Biosimilar Drug) | 101 | 311 | |
| other | Anemia | Blood and lymphatic system disorders | EU-approved Avastin® | 94 | 310 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MB02 (Bevacizumab Biosimilar Drug) | 41 | 311 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | EU-approved Avastin® | 42 | 310 | |
| other | Neutropenia | Blood and lymphatic system disorders | MB02 (Bevacizumab Biosimilar Drug) | 34 | 311 | |
| other | Neutropenia | Blood and lymphatic system disorders | EU-approved Avastin® | 45 | 310 | |
| other | Leukopenia | Blood and lymphatic system disorders | MB02 (Bevacizumab Biosimilar Drug) | 24 | 311 | |
| other | Leukopenia | Blood and lymphatic system disorders | EU-approved Avastin® | 18 | 310 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MB02 (Bevacizumab Biosimilar Drug) | 23 | 311 |
| Total, all-cause mortality | EU-approved Avastin® | 24 | 310 |
| Total, other adverse events | MB02 (Bevacizumab Biosimilar Drug) | 288 | 311 |
| Total, other adverse events | EU-approved Avastin® | 288 | 310 |
| Total, serious adverse events | MB02 (Bevacizumab Biosimilar Drug) | 58 | 311 |
| Total, serious adverse events | EU-approved Avastin® | 54 | 310 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33914256 | DERIVED |
Source PubMed
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 |
|---|---|
| MB02 (Bevacizumab Biosimilar Drug) vs EU-approved Avastin®: deaths from any cause | Trial comparisons |
| MB02 (Bevacizumab Biosimilar Drug) vs EU-approved 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/NCT03296163
GET https://conductscience.org/api/trials/v1/NCT03296163/results?page=2