Clinical trial NCT05456867: A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
Official title: A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC, Non-small-cell Lung Carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-07-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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


Eligibility criteria: 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

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

Primary outcomes:
measure: Safety of durvalumab in patients with unresectable locally advanced NSCLC without progression after CRT in routine practice of the Russian Federation.
timeFrame: Up to 54 month
measure: Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation.
timeFrame: Up to 54 month
measure: 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.
timeFrame: Up to 54 month
measure: Number of irAEs
timeFrame: Up to 54 month
measure: Number of SAEs
timeFrame: Up to 54 month
measure: Number of grade 3-4 AEs
timeFrame: Up to 54 month
measure: Number of post discontinuation irAEs
timeFrame: Up to 54 month
measure: Number of AESIs
timeFrame: Up to 54 month
measure: Number of AEs which lead to discontinuation
timeFrame: Up to 54 month
measure: Time to pneumonitis [median, months]
timeFrame: Up to 54 month
measure: Distribution of pneumonitis grades
timeFrame: Up to 54 month
measure: Nature of pneumonitis by physician diagnosis [radiation or immune-related]
timeFrame: Up to 54 month
measure: Duration of pneumonitis [median, months]
timeFrame: Up to 54 month
Secondary outcomes:
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Grozny
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Research Site
city: Kostroma
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Murmansk
country: Russian Federation
facility: Research Site
city: N.Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Sochi
country: Russian Federation
facility: Research Site
city: Surgut
country: Russian Federation
facility: Research Site
city: Syktyvkar
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Vologda
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Research Site
Study officials:
References: