Using Durvalumab for Extensive-Stage Small Cell Lung Cancer
REAL-WORLD CLINICAL OUTCOMES AMONG PATIENTS INCLUDED IN AN EARLY ACCESS PROGRAMME TREATED WITH DURVALUMAB IN COMBINATION WITH PLATINUM AND ETOPOSIDE AS FIRST-LINE THERAPY IN EXTENSIVE-STAGE SMALL CELL LUNG CANCER: AN ITALIAN MULTICENTER OBSERVATIONAL STUDY
This study looks at how well durvalumab works and how safe it is for people with extensive-stage small cell lung cancer who have already received this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | durvalumab, atezolizumab, chemotherapy, immunotherapy |
| Locations | 13 sites (Bologna and 12 other locations) |
| Trial ID | NCT06826677 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with extensive-stage small cell lung cancer (ES-SCLC) who have previously received durvalumab treatment through an early access program. It aims to gather real-world data on the effectiveness and safety of durvalumab in this patient population. The study will analyze patient outcomes and treatment responses to better understand the potential benefits of durvalumab in managing ES-SCLC. By leveraging data from patients treated in Italy, the study seeks to provide insights into the real-world application of this therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with extensive-stage small cell lung cancer and have received durvalumab treatment.
Not a fit: Patients who do not have a medical chart available or have not received durvalumab treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the effectiveness of durvalumab in improving outcomes for patients with extensive-stage small cell lung cancer.
How similar studies have performed: Other studies have shown promise in using immunotherapy for small cell lung cancer, but this specific approach with durvalumab in a real-world setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with diagnosis of extensive-stage Small Cell Lung Cancer (ES-SCLC). 2. Patients entered, at least 24 months prior to the study inclusion, the D419QR00007 Early Access Programme (CASPIAN EAP) implemented in Italy. 3. Adult patients (aged ≥ 18 years) at the time of inclusion in the CASPIAN EAP. 4. Patients having performed at least one administration of durvalumab treatment in the CASPIAN EAP. 5. Patients (or their legally acceptable representatives) who have signed the subject informed consent and privacy form, if applicable. Exclusion Criteria: 1. Patients with unavailable medical chart.
Where this trial is running
Bologna and 12 other locations
- Research Site — Bologna, Italy (Recruiting)
- Research Site — Catanzaro, Italy (Recruiting)
- Research Site — Lucca, Italy (Recruiting)
- Research Site — Napoli, Italy (Recruiting)
- Research Site — Palermo, Italy (Recruiting)
- Research Site — Pistoia, Italy (Recruiting)
- Research Site — Prato, Italy (Recruiting)
- Research Site — Roma, Italy (Recruiting)
- Research Site — Roma, Italy (Recruiting)
- Research Site — Roma, Italy (Recruiting)
- Research Site — Trento, Italy (Recruiting)
- Research Site — Varese, Italy (Recruiting)
- Research Site — Vimercate, Italy (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.