Durvalumab in Combination With Standard Chemotherapy of Patients With Extensive Stage Small Cell Lung Cancer — DRIVE  

Small-cell Lung Cancer Clinical Trial

Official title: Durvalumab in Combination With Standard Chemotherapy for 1st Line Therapy of Patients With Extensive Stage Small Cell Lung Cancer: A Non-interventional, Prospective Observational Study of Clinical Practice, Quality of Life and Use of Health Resources in Real-world Clinical Practice (DRIVE)

Status Recruiting

Clinical Trial Summary

This is a non-interventional, multicenter, prospective observational study and registry of standard clinical practice in patients with Extensive Stage-Small Cell Lung Cancer (ES-SCLC) receiving 1st line treatment with Durvalumab in combination with standard chemotherapy (cisplatin or carboplatin + etoposide) in the approved indication, which will be carried out in Greece. In this study data will be collected prospectively based on real-world clinical practice. A prospective cohort of atients from centers of the Hellenic Cooperative Oncology Group (HeCOG) will be included. The study will be conducted in hospitals and by physicians specialized in lung cancer from different geographical areas of Greece.

Clinical Trial Description

In this observational prospective study, no changes to current therapeutic practice will be required and all aspects of treatment and clinical management of patients will be in compliance with the local clinical practice and will be left to the discretion of the participating physicians. Patients will be treated in accordance with the study medicine's local prescribing information and standard clinical practice as to the frequency of visits and types of evaluations carried out. The frequency of follow-up visits is set on the basis of standard practice; however, the study-related data will be collected during integration and during the routine clinical visits that will take place after the start of treatment. No visits or measurement/evaluation will be mandatory by the protocol and data collection at the predetermined time-points will be carried out only if the patient visits the center.

Patients will be enrolled during a 12-month recruitment period from HeCOG-participating public and private centers/clinics in Greece with specialization in lung cancer. As part of this study, participating physicians will be asked to follow up each patient for an additional 12 months of treatment at most after last subject is included, or until death, withdrawal of consent, discontinuation of treatment or initiation of new antineoplastic therapy, until completion of the study, or doctor's decision, whichever appears first. Therefore, the maximum period of prospective observation of the study will be 24 months (2 years) from the last patient enrolled in the study. This study will be conducted in accordance with the Guidelines for Good Pharmacoepidemiological Practice, the European General Data Protection Regulation (GDPR) and the applicable regulatory requirements. ;

Related Conditions & MeSH terms

• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

• NCT number: NCT05761977
• Study type: Observational
• Source: Hellenic Cooperative Oncology Group
• Contact: Helena Linardou, MD
• Phone: +302104809339
• Email: elinardou@otenet.gr
• Status: Recruiting
• Start date: March 31, 2021
• Completion date: April 2024