Non-small Cell Lung CancerNCT04889495
A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer
An observational study of Non-small Cell Lung Cancer and Metastatic Colorectal Cancer, run by Pfizer.
Trial summary
This is a prospective, single-arm, open-label, non-interventional, multicenter, post-marketing surveillance to assess the safety and effectiveness of Zirabev(Bevacizumab biosimilar) in domestic patients with non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer
- What is being tested?
- Zirabev
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2025to 16 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: See below
Who may be able to join
None listed.
Who cannot join
- Patients meeting any of the following criteria will not be included in the study:
- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients for whom Zirabev is contraindicated according to the local product document.
About this study
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multicenter, Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Non-small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Advanced or Metastatic Kidney Cancer, Cervical Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer or Glioblastoma Multiforme.
This is a prospective, single-arm, open-label, non-interventional, multicenter, post-marketing surveillance to assess the safety and effectiveness of Zirabev(Bevacizumab biosimilar) in domestic patients with non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or glioblastoma multiforme.
- Conditions
- Non-small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Metastatic Kidney Cancer, Cervical Cancer, Epithelial Ovarian Cancer
- Being tested
- Zirabev
- Keywords
- Zirabev
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Breast Neoplasms, Kidney Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZirabevDrug
Bevacizumab biosimilar
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Zirabev | Participants receiving Zirabev Receives: Drug: Zirabev |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile
The following items that occurred from the baseline:
- Adverse Events (AEs)
- Serious Adverse Events (SAEs)
- Expected Adverse Events (Expected AEs)
- Unexpected Adverse Events (Unexpected AEs)
- Adverse Drug Reactions (ADRs)
- Serious Adverse Drug Reactions (SADRs)
- Expected Adverse Drug Reactions (Expected ADR)
- Unexpected Adverse Drug Reactions (Unexpected ADR)
Measured: baseline up to approximately 4 years
Secondary outcomes (1)
Efficacy profile
OR CR SD PD
- Non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- Four objective response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) (RECIST 1.1)
- Glioblastoma multiforme patients • Four objective response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) (RANO-HGG)
Measured: baseline up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start16 May 2025 (estimated)
- Primary completion16 Aug 2025 (estimated)
- Study completion16 Aug 2025 (estimated)
Why it stopped: The study was withdrawn due to global supply chain issue. Zirabev was not launching in Korea.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889495
- Sponsor's protocol ID
- B7391012
- Other IDs
- NCT04889495
- Status last verified
- Mar 2025
- First submitted
- 12 May 2021
- Last updated
- 19 Mar 2025
- Results posted
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Open-label, Non-interventional, Multicenter, Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Non-small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Advanced or Metastatic Kidney Cancer, Cervical Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer or Glioblastoma Multiforme.
- ClinicalTrials.gov ID
- NCT04889495
- Acronym / sponsor ID
- B7391012
- Conditions
- Non-small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Metastatic Kidney Cancer, Cervical Cancer, Epithelial Ovarian Cancer
- Keywords
- Zirabev
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to global supply chain issue. Zirabev was not launching in Korea.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 16 May 2025 (estimated)
- Primary completion
- 16 Aug 2025 (estimated)
- Study completion
- 16 Aug 2025 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, open-label, non-interventional, multicenter, post-marketing surveillance to assess the safety and effectiveness of Zirabev(Bevacizumab biosimilar) in domestic patients with non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or glioblastoma multiforme.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Zirabev | – | Drug: ZirabevParticipants receiving Zirabev |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See below
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients for whom Zirabev is contraindicated according to the local product document.
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 |
|---|---|---|
| ZirabevBevacizumab biosimilar | Drug | Participants receiving Zirabev |
Primary outcome
Safety profile
Time frame: baseline up to approximately 4 years
The following items that occurred from the baseline: 1. Adverse Events (AEs) 2. Serious Adverse Events (SAEs) 3. Expected Adverse Events (Expected AEs) 4. Unexpected Adverse Events (Unexpected AEs) 5. Adverse Drug Reactions (ADRs) 6. Serious Adverse Drug Reactions (SADRs) 7. Expected Adverse Drug Reactions (Expected ADR) 8. Unexpected Adverse Drug Reactions (Unexpected ADR)
1 secondary outcome
Efficacy profile
Time frame: baseline up to approximately 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and Metastatic Colorectal Cancer, run by Pfizer.
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 0 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety profile (time frame: baseline up to approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2025.