NSCLC, Non-small-cell Lung CarcinomaNIS durvalumabNCT05456867
A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
An observational study of NSCLC, Non-small-cell Lung Carcinoma, run by AstraZeneca at 22 sites in Russia.
Trial summary
Durvalumab was approved in the Russian Federation for use after both concurrent and subsequent CRT until disease progression. Currently, there is no real-world data regarding the safety and real world effectiveness of durvalumab in this indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Non-small-cell Lung Carcinoma
- How many people
- 250 participants
- Where
- 22 sitesRussia
- Study dates
- 31 May 2022to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study may include all patients who have received the first dose of durvalumab prior to study participation. To enter in the study, patients must have completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression. There is no fixed maximum duration for durvalumab treatment. Treatment with durvalumab continues until the physician determines that it is in the patient's best interest to stop therapy. It is expected to recruit 300 patients from approximately 25 cites.
Who may be able to join
- Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply:
- Written informed consent obtained from the patient prior to performing any protocol-related procedures
- Age ≥18 years at time of study entry
- Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 8)
- Patients must have completed a platinum-based chemotherapy with radiation therapy (concurrent or sequential) without evidence of disease progression
- Patients must have been treated with at least one dose of durvalumab
Who cannot join
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- Absence or missing of written informed consent form
- Patients treated with durvalumab in clinical studies
- Absence of essential data to obtain all necessary information
- Confirmation that the subject was already included in this study before
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Russia22 sites
Research Site
Arkhangelsk
Research Site
Chelyabinsk
Research Site
Grozny
Research Site
Irkutsk
Research Site
Khanty-Mansiysk
Research Site
Kostroma
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Murmansk
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Perm
Research Site
Saint Petersburg
Research Site
Sochi
Research Site
Surgut
Research Site
Tomsk
Research Site
Ufa
Research Site
Vologda
Research Site
Yaroslavl
Research Site
Yekaterinburg
Research Site
Yuzhno-Sakhalinsk
About this study
Durvalumab was approved in the Russian Federation for use after both concurrent and subsequent CRT until disease progression. Currently, there is no real-world data regarding the safety and real world effectiveness of durvalumab in this indication. Moreover, generation data on the safety and real world effectiveness of durvalumab after concurrent chemo-radiation therapy (cCRT) and subsequent chemo-radiation therapy (sCRT) in routine practice in the Russian Federation will be of high relevance.
The other important question that needs to be addressed is the duration of treatment with durvalumab and its' influence on the relevant outcomes. According to the Russian label, it is possible to continue treatment with durvalumab until disease progression, although current data from the PACIFIC trial provide the results on 12 months duration of durvalumab treatment. The real-world data about the duration of treatment with durvalumab in the Russian population and its' influence on various outcomes would be very important.
Among other goals, the current study is aimed to analyze factors influencing the effectiveness of durvalumab therapy in the real-world setting (e.g. duration of treatment, delays in the start of treatment with durvalumab after CRT over, early discontinuation due to any factors including AEs, etc.). The study also aims to elucidate treatment approaches after discontinuation from durvalumab (post-progression outcomes and treatment in case of discontinuation due to AEs). This study will support the understanding of described factors and will take and an attempt to optimize the treatment process to improve outcomes for patients
- Conditions
- NSCLC, Non-small-cell Lung Carcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of durvalumab in patients with unresectable locally advanced NSCLC without progression after CRT in routine practice of the Russian Federation.
Measured: Up to 54 month
Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation.
Measured: Up to 54 month
Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation separately for fix dose (1500mg every 4 weeks) and 10mg/kg every 2 weeks dosage.
Measured: Up to 54 month
Number of irAEs
Measured: Up to 54 month
Number of SAEs
Measured: Up to 54 month
Number of grade 3-4 AEs
Measured: Up to 54 month
Number of post discontinuation irAEs
Measured: Up to 54 month
Number of AESIs
Measured: Up to 54 month
Number of AEs which lead to discontinuation
Measured: Up to 54 month
Time to pneumonitis [median, months]
Measured: Up to 54 month
Distribution of pneumonitis grades
Measured: Up to 54 month
Nature of pneumonitis by physician diagnosis [radiation or immune-related]
Measured: Up to 54 month
Duration of pneumonitis [median, months]
Measured: Up to 54 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start31 May 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Non-small-cell Lung CarcinomaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456867
- Sponsor's protocol ID
- D4194R00027
- Acronym
- NIS durvalumab
- Status last verified
- Mar 2026
- First submitted
- 26 May 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
- ClinicalTrials.gov ID
- NCT05456867
- Acronym / sponsor ID
- NIS durvalumab / D4194R00027
- Conditions
- NSCLC, Non-small-cell Lung Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 Jul 2022 (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.
Durvalumab was approved in the Russian Federation for use after both concurrent and subsequent CRT until disease progression. Currently, there is no real-world data regarding the safety and real world effectiveness of durvalumab in this indication. Moreover, generation data on the safety and real world effectiveness of durvalumab after concurrent chemo-radiation therapy (cCRT) and subsequent chemo-radiation therapy (sCRT) in routine practice in the Russian Federation will be of high relevance.
The other important question that needs to be addressed is the duration of treatment with durvalumab and its' influence on the relevant outcomes. According to the Russian label, it is possible to continue treatment with durvalumab until disease progression, although current data from the PACIFIC trial provide the results on 12 months duration of durvalumab treatment. The real-world data about the duration of treatment with durvalumab in the Russian population and its' influence on various outcomes would be very important.
Among other goals, the current study is aimed to analyze factors influencing the effectiveness of durvalumab therapy in the real-world setting (e.g. duration of treatment, delays in the start of treatment with durvalumab after CRT over, early discontinuation due to any factors including AEs, etc.). The study also aims to elucidate treatment approaches after discontinuation from durvalumab (post-progression outcomes and treatment in case of discontinuation due to AEs). This study will support the understanding of described factors and will take and an attempt to optimize the treatment process to improve outcomes for patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study may include all patients who have received the first dose of durvalumab prior to study participation. To enter in the study, patients must have completed a platinum-based chemotherapy concurrently or sequentially with radiation therapy without evidence of disease progression. There is no fixed maximum duration for durvalumab treatment. Treatment with durvalumab continues until the physician determines that it is in the patient's best interest to stop therapy. It is expected to recruit 300 patients from approximately 25 cites.
Key inclusion criteria (6 listed)
- Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply:
- Written informed consent obtained from the patient prior to performing any protocol-related procedures
- Age ≥18 years at time of study entry
- Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 8)
- Patients must have completed a platinum-based chemotherapy with radiation therapy (concurrent or sequential) without evidence of disease progression
Key exclusion criteria (5 listed)
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- Absence or missing of written informed consent form
- Patients treated with durvalumab in clinical studies
- Absence of essential data to obtain all necessary information
- Confirmation that the subject was already included in this study before
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 of durvalumab in patients with unresectable locally advanced NSCLC without progression after CRT in routine practice of the Russian Federation.
Time frame: Up to 54 month
Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation.
Time frame: Up to 54 month
Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation separately for fix dose (1500mg every 4 weeks) and 10mg/kg every 2 weeks dosage.
Time frame: Up to 54 month
Number of irAEs
Time frame: Up to 54 month
Number of SAEs
Time frame: Up to 54 month
Number of grade 3-4 AEs
Time frame: Up to 54 month
Number of post discontinuation irAEs
Time frame: Up to 54 month
Number of AESIs
Time frame: Up to 54 month
Number of AEs which lead to discontinuation
Time frame: Up to 54 month
Time to pneumonitis [median, months]
Time frame: Up to 54 month
Distribution of pneumonitis grades
Time frame: Up to 54 month
Nature of pneumonitis by physician diagnosis [radiation or immune-related]
Time frame: Up to 54 month
Duration of pneumonitis [median, months]
Time frame: Up to 54 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, Non-small-cell Lung Carcinoma, run by AstraZeneca at 22 sites in Russia.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Russia. 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?
This study is still under way. Results are not available in the source record yet.
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 of durvalumab in patients with unresectable locally advanced NSCLC without progression after CRT in routine practice of the Russian Federation. (time frame: Up to 54 month). The study lists 13 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 Mar 2026.