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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05456867




Registration number
NCT05456867
Ethics application status
Date submitted
26/05/2022
Date registered
13/07/2022
Date last updated
1/10/2024

Titles & IDs
Public title
A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
Scientific title
A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
Secondary ID [1] 0 0
D4194R00027
Universal Trial Number (UTN)
Trial acronym
NIS durvalumab
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC, Non-small-cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of durvalumab in patients with unresectable locally advanced NSCLC without progression after CRT in routine practice of the Russian Federation.
Timepoint [1] 0 0
Up to 54 month
Primary outcome [2] 0 0
Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation.
Timepoint [2] 0 0
Up to 54 month
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to 54 month
Primary outcome [4] 0 0
Number of irAEs
Timepoint [4] 0 0
Up to 54 month
Primary outcome [5] 0 0
Number of SAEs
Timepoint [5] 0 0
Up to 54 month
Primary outcome [6] 0 0
Number of grade 3-4 AEs
Timepoint [6] 0 0
Up to 54 month
Primary outcome [7] 0 0
Number of post discontinuation irAEs
Timepoint [7] 0 0
Up to 54 month
Primary outcome [8] 0 0
Number of AESIs
Timepoint [8] 0 0
Up to 54 month
Primary outcome [9] 0 0
Number of AEs which lead to discontinuation
Timepoint [9] 0 0
Up to 54 month
Primary outcome [10] 0 0
Time to pneumonitis [median, months]
Timepoint [10] 0 0
Up to 54 month
Primary outcome [11] 0 0
Distribution of pneumonitis grades
Timepoint [11] 0 0
Up to 54 month
Primary outcome [12] 0 0
Nature of pneumonitis by physician diagnosis [radiation or immune-related]
Timepoint [12] 0 0
Up to 54 month
Primary outcome [13] 0 0
Duration of pneumonitis [median, months]
Timepoint [13] 0 0
Up to 54 month

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Russian Federation
State/province [1] 0 0
Arkhangelsk
Country [2] 0 0
Russian Federation
State/province [2] 0 0
Chelyabinsk
Country [3] 0 0
Russian Federation
State/province [3] 0 0
Ekaterinburg
Country [4] 0 0
Russian Federation
State/province [4] 0 0
Grozny
Country [5] 0 0
Russian Federation
State/province [5] 0 0
Irkutsk
Country [6] 0 0
Russian Federation
State/province [6] 0 0
Kemerovo
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Khanty-Mansiysk
Country [8] 0 0
Russian Federation
State/province [8] 0 0
Kostroma
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Krasnodar
Country [10] 0 0
Russian Federation
State/province [10] 0 0
Krasnoyarsk
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Moscow
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Murmansk
Country [13] 0 0
Russian Federation
State/province [13] 0 0
N.Novgorod
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Novosibirsk
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Perm
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Saint-Petersburg
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Sochi
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Surgut
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Syktyvkar
Country [20] 0 0
Russian Federation
State/province [20] 0 0
Tomsk
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Ufa
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Vologda
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Yaroslavl
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Yuzhno-Sakhalinsk

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05456867