Carcinoma, Non-Small-Cell LungNCT03643484
IMFINZI Specific-Clinical Experience Investigation in Patients With NSCLC After Definitive Chemoradiation Therapy
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 37 sites in Japan.
Trial summary
To investigate the impact of presence/absence or grade of radiation pneumonitis before starting IMFINZI, on the onset of interstitial lung disease (including radiation pneumonitis) after starting IMFINZI, in the real world in patients with locally advanced unresectable non-small cell lung cancer who are treated with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 634 participants
- Where
- 37 sitesJapan
- Study dates
- 24 Oct 2018to 30 Jun 2021
- How long will I take part?
- 12 Months
- 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 locally advanced unresectable non-small cell lung cancer after definitive chemoradiation therapy
Who may be able to join
- -Patients with locally advanced unresectable non-small cell lung cancer who are treated with IMFINZI for the first time as maintenance therapy after definitive chemoradiation therapy
Who cannot join
- -No past history of hypersensitivity to the components of IMFINZI
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Japan37 sites
Research Site
Aichi, D4194C00003
Research Site
Akita, D4194C00003
Research Site
Aomori, D4194C00003
Research Site
Chiba, D4194C00003
Research Site
Fukuoka, D4194C00003
Research Site
Fukushima, D4194C00003
Research Site
Gifu, D4194C00003
Research Site
Gunma, D4194C00003
Research Site
Hiroshima, D4194C00003
Research Site
Hokkaido, D4194C00003
Research Site
Hyōgo, D4194C00003
Research Site
Ibaraki, D4194C00003
Research Site
Ishikawa, D4194C00003
Research Site
Ishikawa
Research Site
Kagawa, D4194C00003
Research Site
Kanagawa, D4194C00003
Research Site
Kumamoto, D4194C00003
Research Site
Kyoto, D4194C00003
Research Site
Mie, D4194C00003
Research Site
Miyagi, D4194C00003
Research Site
Miyazaki, D4194C00003
Research Site
Nagano, D4194C00003
Research Site
Nagasaki, D4194C00003
Research Site
Nara, D4194C00003
Research Site
Niigata, D4194C00003
Research Site
Okayama, D4194C00003
Research Site
Osaka, D4194C00003
Research Site
Saitama, D4194C00003
Research Site
Shiga, D4194C00003
Research Site
Shizuoka, D4194C00003
Research Site
Tochigi, D4194C00003
Research Site
Tokyo, D4194C00003
Research Site
Tottori, D4194C00003
Research Site
Toyama, D4194C00003
Research Site
Yamagata, D4194C00003
Research Site
Yamaguchi, D4194C00003
Research Site
Yamanashi, D4194C00003
About this study
Official title: IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer Who Are Treated With Maintenance Therapy After Definitive Chemoradiation Therapy.
To investigate the impact of presence/absence or grade of radiation pneumonitis before starting IMFINZI, on the onset of interstitial lung disease (including radiation pneumonitis) after starting IMFINZI, in the real world in patients with locally advanced unresectable non-small cell lung cancer who are treated with the product as maintenance therapy after definitive chemoradiation therapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Lung Diseases, Interstitial, Radiation Pneumonitis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Diseases, Interstitial, Radiation Pneumonitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Interstitial lung disease (including radiation pneumonitis) by post-chemoradiation therapy radiation pneumonitis (yes/no) and by severity (CTCAE grade)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start24 Oct 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 634 participants (actual)
- Target duration
- 12 Months
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
- NCT03643484
- Sponsor's protocol ID
- D4194C00003
- Status last verified
- Feb 2024
- First submitted
- 21 Aug 2018
- Last updated
- 21 Feb 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 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 Locally Advanced Unresectable Non-small Cell Lung Cancer Who Are Treated With Maintenance Therapy After Definitive Chemoradiation Therapy.
- ClinicalTrials.gov ID
- NCT03643484
- Acronym / sponsor ID
- D4194C00003
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Lung Diseases, Interstitial, Radiation Pneumonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Aug 2018 (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 investigate the impact of presence/absence or grade of radiation pneumonitis before starting IMFINZI, on the onset of interstitial lung disease (including radiation pneumonitis) after starting IMFINZI, in the real world in patients with locally advanced unresectable non-small cell lung cancer who are treated with the product as maintenance therapy after definitive chemoradiation therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with locally advanced unresectable non-small cell lung cancer after definitive chemoradiation therapy
Key inclusion criteria (1 listed)
- -Patients with locally advanced unresectable non-small cell lung cancer who are treated with IMFINZI for the first time as maintenance therapy after definitive chemoradiation therapy
Key exclusion criteria (1 listed)
- -No past history of hypersensitivity to the components of IMFINZI
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 Interstitial lung disease (including radiation pneumonitis) by post-chemoradiation therapy radiation pneumonitis (yes/no) and by severity (CTCAE grade)
Time frame: 12 months
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 21 Feb 2024.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
37 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, Non-Small-Cell Lung, run by AstraZeneca at 37 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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 Interstitial lung disease (including radiation pneumonitis) by post-chemoradiation therapy radiation pneumonitis (yes/no) and by severity (CTCAE grade) (time frame: 12 months). 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 21 Feb 2024.