Observational study of durvalumab for advanced lung cancer in Russia
A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
This study is trying to see how safe and effective the drug durvalumab is for people in Russia with advanced lung cancer after they've had chemotherapy and radiation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | durvalumab, chemotherapy, radiation |
| Locations | 24 sites (Arkhangelsk and 23 other locations) |
| Trial ID | NCT05456867 on ClinicalTrials.gov |
What this trial studies
This study aims to gather real-world data on the safety and effectiveness of durvalumab in patients with unresectable locally advanced non-small-cell lung carcinoma (NSCLC) following chemotherapy and radiation therapy in Russia. It will assess the treatment duration of durvalumab and its impact on patient outcomes, addressing a gap in knowledge regarding its use in routine clinical practice. The study will include patients who have received at least one dose of durvalumab after completing their initial treatment without disease progression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically or cytologically confirmed locally advanced unresectable NSCLC who have completed platinum-based chemotherapy and radiation therapy.
Not a fit: Patients who have not received durvalumab or those who have participated in clinical trials involving durvalumab will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of durvalumab, potentially improving treatment strategies for patients with advanced NSCLC.
How similar studies have performed: While this study focuses on real-world data, similar studies on durvalumab have shown promising results in controlled settings, indicating potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Arkhangelsk and 23 other locations
- Research Site — Arkhangelsk, Russian Federation (Recruiting)
- Research Site — Chelyabinsk, Russian Federation (Recruiting)
- Research Site — Ekaterinburg, Russian Federation (Recruiting)
- Research Site — Grozny, Russian Federation (Recruiting)
- Research Site — Irkutsk, Russian Federation (Recruiting)
- Research Site — Kemerovo, Russian Federation (Not_yet_recruiting)
- Research Site — Khanty-Mansiysk, Russian Federation (Recruiting)
- Research Site — Kostroma, Russian Federation (Recruiting)
- Research Site — Krasnodar, Russian Federation (Not_yet_recruiting)
- Research Site — Krasnoyarsk, Russian Federation (Recruiting)
- Research Site — Moscow, Russian Federation (Recruiting)
- Research Site — Murmansk, Russian Federation (Recruiting)
- Research Site — N.Novgorod, Russian Federation (Recruiting)
- Research Site — Novosibirsk, Russian Federation (Recruiting)
- Research Site — Perm, Russian Federation (Recruiting)
- Research Site — Saint-Petersburg, Russian Federation (Recruiting)
- Research Site — Sochi, Russian Federation (Recruiting)
- Research Site — Surgut, Russian Federation (Recruiting)
- Research Site — Syktyvkar, Russian Federation (Not_yet_recruiting)
- Research Site — Tomsk, Russian Federation (Recruiting)
- Research Site — Ufa, Russian Federation (Recruiting)
- Research Site — Vologda, Russian Federation (Recruiting)
- Research Site — Yaroslavl, Russian Federation (Recruiting)
- Research Site — Yuzhno-Sakhalinsk, Russian Federation (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.