Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05456867

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

NSCLC, Non-small-cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arkhangelsk, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Number of irAEs

    Time frame: Up to 54 month

  5. Number of SAEs

    Time frame: Up to 54 month

  6. Number of grade 3-4 AEs

    Time frame: Up to 54 month

  7. Number of post discontinuation irAEs

    Time frame: Up to 54 month

  8. Number of AESIs

    Time frame: Up to 54 month

  9. Number of AEs which lead to discontinuation

    Time frame: Up to 54 month

  10. Time to pneumonitis [median, months]

    Time frame: Up to 54 month

  11. Distribution of pneumonitis grades

    Time frame: Up to 54 month

  12. Nature of pneumonitis by physician diagnosis [radiation or immune-related]

    Time frame: Up to 54 month

  13. Duration of pneumonitis [median, months]

    Time frame: Up to 54 month

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: NIS durvalumab

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.