Carcinoma, Small CellNCT04854590
IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer
An observational study of Carcinoma, Small Cell, run by AstraZeneca at 18 sites in Japan.
Trial summary
To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Small Cell
- How many people
- 248 participants
- Where
- 18 sitesJapan
- Study dates
- 22 Apr 2021to 25 Jul 2023
- How long will I take part?
- 16 Weeks
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with extensive stage small cell lung cancer
Who may be able to join
- -Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.
Who cannot join
- -Patients who have no treatment history with the product (i.e.,durvalumab)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Research Site
Chiba
Research Site
Fukuoka
Research Site
Gunma
Research Site
Hokkaido
Research Site
Hyōgo
Research Site
Kanagawa
Research Site
Miyagi
Research Site
Nagano
Research Site
Nagasaki
Research Site
Nara
Research Site
Numakunai
Research Site
Okayama
Research Site
Osaka
Research Site
Saitama
Research Site
Shizuoka
Research Site
Tokyo
Research Site
Tottori
Research Site
Wakayama
About this study
Official title: IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Extensive Stage Small Cell Lung Cancer
To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch
Read the detailed description
To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.
- Conditions
- Carcinoma, Small Cell
- Medical subject headings
- Carcinoma, Small Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade)
Measured: 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start22 Apr 2021
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Small CellStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshimitsu Tokimoto, Study director, Astrazeneca KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854590
- Sponsor's protocol ID
- D419QC00006
- Status last verified
- Jul 2024
- First submitted
- 19 Apr 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04854590
- Acronym / sponsor ID
- D419QC00006
- Conditions
- Carcinoma, Small Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 22 Apr 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.
To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch
Detailed description
To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with extensive stage small cell lung cancer
Key inclusion criteria (1 listed)
- -Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.
Key exclusion criteria (1 listed)
- -Patients who have no treatment history with the product (i.e.,durvalumab)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade)
Time frame: 16weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Toshimitsu Tokimoto study director
Astrazeneca KK
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Small Cell, run by AstraZeneca at 18 sites in Japan.
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 1 inclusion and 1 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade) (time frame: 16weeks). 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 24 Jul 2024.