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 Type
OBSERVATIONAL
Enrollment
250
Research Site
Arkhangelsk, Russia
Research Site
Chelyabinsk, Russia
Research Site
Grozny, Russia
Research Site
Irkutsk, Russia
Research Site
Khanty-Mansiysk, Russia
Research Site
Kostroma, Russia
Research Site
Krasnodar, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Moscow, Russia
Research Site
Murmansk, Russia
...and 12 more locations
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
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