A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia

Status: Recruiting
Location: See all (24) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Russian Federation
Research Site
RECRUITING
Arkhangelsk
Research Site
RECRUITING
Chelyabinsk
Research Site
RECRUITING
Grozny
Research Site
RECRUITING
Irkutsk
Research Site
NOT_YET_RECRUITING
Kemerovo
Research Site
RECRUITING
Khanty-mansiysk
Research Site
RECRUITING
Kostroma
Research Site
NOT_YET_RECRUITING
Krasnodar
Research Site
RECRUITING
Krasnoyarsk
Research Site
RECRUITING
Moscow
Research Site
RECRUITING
Murmansk
Research Site
RECRUITING
N.novgorod
Research Site
RECRUITING
Novosibirsk
Research Site
RECRUITING
Perm
Research Site
RECRUITING
Saint Petersburg
Research Site
RECRUITING
Sochi
Research Site
RECRUITING
Surgut
Research Site
NOT_YET_RECRUITING
Syktyvkar
Research Site
RECRUITING
Tomsk
Research Site
RECRUITING
Ufa
Research Site
RECRUITING
Vologda
Research Site
RECRUITING
Yaroslavl
Research Site
RECRUITING
Yekaterinburg
Research Site
RECRUITING
Yuzhno-sakhalinsk
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2022-05-31
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 250
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov