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

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 Overview

• Status: Active, not recruiting
• Conditions: NSCLC, Non-small-cell Lung Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Russia
  • 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
    • Research Site
  • Nizhny Novgorod, Russia
    • Research Site
  • Novosibirsk, Russia
    • Research Site
  • Perm, Russia
    • Research Site
  • Saint Petersburg, Russia
    • Research Site
  • Sochi, Russia
    • Research Site
  • Surgut, Russia
    • Research Site
  • Tomsk, Russia
    • Research Site
  • Ufa, Russia
    • Research Site
  • Vologda, Russia
    • Research Site
  • Yaroslavl, Russia
    • Research Site
  • Yekaterinburg, Russia
    • Research Site
  • Yuzhno-Sakhalinsk, Russia
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of durvalumab in patients with unresectable locally advanced NSCLC without progression after CRT in routine practice of the Russian Federation.	Up to 54 month
Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation.	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.	Up to 54 month
Number of irAEs	Up to 54 month
Number of SAEs	Up to 54 month
Number of grade 3-4 AEs	Up to 54 month
Number of post discontinuation irAEs	Up to 54 month
Number of AESIs	Up to 54 month
Number of AEs which lead to discontinuation	Up to 54 month
Time to pneumonitis [median, months]	Up to 54 month
Distribution of pneumonitis grades	Up to 54 month
Nature of pneumonitis by physician diagnosis [radiation or immune-related]	Up to 54 month
Duration of pneumonitis [median, months]	Up to 54 month

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D4194R00027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No