Lung Cancer, Biliary Tract CancerImfinzi PMSNCT04068168
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
An observational study of Lung Cancer, Biliary Tract Cancer, run by AstraZeneca at 24 sites in South Korea.
Trial summary
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Biliary Tract Cancer
- How many people
- 712 participants
- Where
- 24 sitesSouth Korea
- Study dates
- 30 Jan 2020to 27 Dec 2024
- 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: Imfinzi treatment according to the approved label
Who may be able to join
- Eligible for Imfinzi treatment according to the approved label
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
Who cannot join
- Current participation in any interventional trial
- Other off-label indications according to the approved label
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
South Korea24 sites
Research Site
Anyang-si, South Korea
Research Site
Bucheon-si, South Korea
Research Site
Busan, South Korea
Research Site
Changwon, South Korea
Research Site
Changwon-si, South Korea
Research Site
Cheonan, South Korea
Research Site
Chuncheon, South Korea
Research Site
Daegu, South Korea
Research Site
Daejeon, South Korea
Research Site
Goyang-si, South Korea
Research Site
Gwangju, South Korea
Research Site
Hwasun-gun, South Korea
Research Site
Iksan-si, South Korea
Research Site
Incheon, South Korea
Research Site
Jeju-do, South Korea
Research Site
Jeonju, South Korea
Research Site
Pohang-si, South Korea
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea
Research Site
Suwon, South Korea
Research Site
Uijeongbu-si, South Korea
Research Site
Wŏnju, South Korea
Research Site
Yangsan, South Korea
Research Site
Yongin-si, South Korea
About this study
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
Read the detailed description
Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
- Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
- Dose interruptions
- Duration of treatment
- Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
- Progression free survival (PFS)
- Objective response rate (ORR)
- Duration of response (DoR)
- Conditions
- Lung Cancer, Biliary Tract Cancer
- Medical subject headings
- Lung Neoplasms, Biliary Tract Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)
safety outcome
Measured: for up to 1 year after the first dose of Imfinzi
Dose interruptions
Safety outcome
Measured: for up to 1 year after the first dose of Imfinzi
Duration of treatment
Safety outcome
Measured: for up to 1 year after the first dose of Imfinzi
Secondary outcomes (3)
Progression free survival (PFS)
efficacy outcome
Measured: for up to 1 year after the first dose of Imfinzi
Objective response rate (ORR)
efficacy outcome
Measured: for up to 1 year after the first dose of Imfinzi
Duration of response (DoR)
efficacy outcome
Measured: for up to 1 year after the first dose of Imfinzi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start30 Jan 2020
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Biliary Tract CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068168
- Sponsor's protocol ID
- D4194R00004
- Acronym
- Imfinzi PMS
- Status last verified
- Nov 2025
- First submitted
- 7 Aug 2019
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
- ClinicalTrials.gov ID
- NCT04068168
- Acronym / sponsor ID
- Imfinzi PMS / D4194R00004
- Conditions
- Lung Cancer, Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 28 Aug 2019 (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.
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
Detailed description
Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
- Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
- Dose interruptions
- Duration of treatment
- Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
- Progression free survival (PFS)
- Objective response rate (ORR)
- Duration of response (DoR)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Imfinzi treatment according to the approved label
Key inclusion criteria (2 listed)
- Eligible for Imfinzi treatment according to the approved label
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
Key exclusion criteria (2 listed)
- Current participation in any interventional trial
- Other off-label indications according to the approved label
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
Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)
Time frame: for up to 1 year after the first dose of Imfinzi
safety outcome
Dose interruptions
Time frame: for up to 1 year after the first dose of Imfinzi
Safety outcome
Duration of treatment
Time frame: for up to 1 year after the first dose of Imfinzi
Safety outcome
3 secondary outcomes
Progression free survival (PFS)
Time frame: for up to 1 year after the first dose of Imfinzi
Objective response rate (ORR)
Time frame: for up to 1 year after the first dose of Imfinzi
Duration of response (DoR)
Time frame: for up to 1 year after the first dose of Imfinzi
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 17 Nov 2025.
- CSR Synopsis\_RedactedLink 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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Biliary Tract Cancer, run by AstraZeneca at 24 sites in South Korea.
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 2 inclusion and 2 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in South Korea. 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?
Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE) (time frame: for up to 1 year after the first dose of Imfinzi). The study lists 3 primary outcomes in all. 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 17 Nov 2025.