Durvalumab After Chemoradiotherapy in Limited Stage Small Cell Lung Cancer.
Lung cancer is a highly prevalent disease worldwide in women and men. In 2022, lung cancer stood as the most frequently diagnosed cancer with approximately 2.48 million new cases on a global scale, followed by cancers of the female breast (11.6%), colorectum (9.6%), prostate (7.3%), and stomach (4.9%). Lung cancer is t
| Condition(s) | Small Cell Lung Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Lung cancer is a highly prevalent disease worldwide in women and men. In 2022, lung cancer stood as the most frequently diagnosed cancer with approximately 2.48 million new cases on a global scale, followed by cancers of the female breast (11.6%), colorectum (9.6%), prostate (7.3%), and stomach (4.9%). Lung cancer is the leading cause of cancer death worldwide according to data provided by the International Agency for Research on Cancer. In 2022 they estimated a 1.8 million deaths across the world. Specifically in Spain, from 1980 to 2022, lung cancer led to 745,182 deaths. Histologically, lung cancer (LC) can be classified into two major subtypes: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), accounting for 85% and 15% of LC patients, respectively. Smoking is the m |
| Who can participate | Inclusion Criteria: * Female or male patients aged ≥18 years at the time of signing the Informed Consent Form (ICF). * Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures. Additionally, signed and dated written genetic and/or biomarker informed consents, respectively, to collect baseline tissue and blood samples for future translational biomarker assessment at baseline, at the initiation of durvalumab maintenance treatment (cycles 1, 2, 3, 4, 7, 10, 13, 19, 26), and at end of treatment/progression. * Patients must have histologically or cytologically documented limited stage SCLC (stage I-III SCLC \[T any, N any, M0\] according to the AJCC Cancer Staging Manual, \[8th Edition\] or the IASLC Staging Manual in Thoracic O |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Lead sponsor | AstraZeneca |
| Locations | A Coruña, Spain; Badajoz, Spain; Barakaldo, Spain; Barcelona, Spain; Barcelona, Spain; Barcelona, Spain (+9 more sites) |
| Start date | 2025-09-15 |
| NCT ID | NCT06992609 |
| Official listing | https://clinicaltrials.gov/study/NCT06992609 |