NCT05456867Active, not recruiting
A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 26 May 2022
- Start date
- 31 May 2022
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Lung cancer
- NCT number
- NCT05456867
What you commit to
- Study type: Observational
- Planned participants: 250
- From 31 May 2022 to the primary completion date, 30 Nov 2026
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with durvalumab in clinical studies
Other
- 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
- Absence of essential data to obtain all necessary information
- Confirmation that the subject was already included in this study before
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.