Examining treatment patterns and outcomes for advanced lung cancer in Russia
National Multicentre Non-interventional Study to Assess CRT Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia
This study looks at how patients with advanced lung cancer in Russia are treated and what their outcomes are after receiving chemoradiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | durvalumab |
| Locations | 41 sites (Arkhangelsk and 40 other locations) |
| Trial ID | NCT05887011 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the routine diagnostic and treatment practices for patients with unresectable locally advanced non-small cell lung cancer (NSCLC) and limited-stage small cell lung cancer (SCLC) across 50 major oncology centers in Russia. Over a two-year period, data will be collected from the medical records of approximately 2000 patients receiving chemoradiation therapy (CRT). The study will focus on demographic and clinical characteristics, treatment approaches, and outcomes at the end of CRT, while adhering to local regulatory requirements for adverse event reporting. The study will not collect data on specific post-CRT treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with unresectable locally advanced NSCLC or limited-stage SCLC who are currently undergoing radiotherapy as part of their treatment.
Not a fit: Patients who have participated in another clinical study with an investigational product in the last three months or those without written informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of current treatment practices for advanced lung cancer, potentially leading to improved patient outcomes.
How similar studies have performed: While this study focuses on routine practices in Russia, similar observational studies in other regions have provided valuable data on treatment outcomes, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old 2. Provision of written informed consent 3. Patient received at least one RT dose under prescribed CRT (concurrent or sequential) for definitive treatment of locally advanced NSCLC (stage II-III, unresectable or inoperable NSCLC, including locoregional recurrence and patient's refusal to undergo surgery) or LS-SCLC based on local MDT decision 4. Patient is currently undergoing RT (preferably no more than 10 doses) Exclusion Criteria: 1. Participation in another clinical study with an investigational product during the last 3 months 2. Confirmation that the subject was already included in this study before 3. Absence of written informed consent form 4. Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database.
Where this trial is running
Arkhangelsk and 40 other locations
- Research Site — Arkhangelsk, Russia (Recruiting)
- Research Site — Balashikha, Russia (Recruiting)
- Research Site — Barnaul, Russia (Recruiting)
- Research Site — Chelyabinsk, Russia (Withdrawn)
- Research Site — Grozny, Russia (Recruiting)
- Research Site — Irkutsk, Russia (Recruiting)
- Research Site — Ivanovo, Russia (Recruiting)
- Research Site — Izhevsk, Russia (Withdrawn)
- Research Site — Kaluga, Russia (Recruiting)
- Research Site — Kazan', Russia (Recruiting)
- Research Site — Kemerovo, Russia (Recruiting)
- Research Site — Khabarovsk, Russia (Recruiting)
- Research Site — Khanty-Mansiysk, Russia (Recruiting)
- Research Site — Kirov, Russia (Recruiting)
- Research Site — Kostroma, Russia (Recruiting)
- Research Site — Krasnodar, Russia (Recruiting)
- Research Site — Krasnoyarsk, Russia (Recruiting)
- Research Site — Moscow, Russia (Recruiting)
- Research Site — Moscow, Russia (Withdrawn)
- Research Site — Nizhny Novgorod, Russia (Recruiting)
- Research Site — Novokuznetsk, Russia (Recruiting)
- Research Site — Novosibirsk, Russia (Recruiting)
- Research Site — Obninsk, Russia (Recruiting)
- Research Site — Perm, Russia (Recruiting)
- Research Site — Podolsk, Russia (Recruiting)
- Research Site — Rostov-on-Don, Russia (Recruiting)
- Research Site — Ryazan, Russia (Recruiting)
- Research Site — Saint Petersburg, Russia (Recruiting)
- Research Site — Saransk, Russia (Recruiting)
- Research Site — Saratov, Russia (Recruiting)
- Research Site — Sochi, Russia (Recruiting)
- Research Site — Syktivkar, Russia (Withdrawn)
- Research Site — Tula, Russia (Recruiting)
- Research Site — Tver', Russia (Recruiting)
- Research Site — Ulyanovsk, Russia (Recruiting)
- Research Site — Vladivostok, Russia (Recruiting)
- Research Site — Vologda, Russia (Recruiting)
- Research Site — Yakutia, Russia (Recruiting)
- Research Site — Yaroslavl, Russia (Recruiting)
- Research Site — Yekaterinburg, Russia (Recruiting)
- Research Site — Yuzhno-Sakhalinsk, Russia (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.