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

Launched by HELLENIC COOPERATIVE ONCOLOGY GROUP · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of Durvalumab, an immunotherapy drug, combined with standard chemotherapy for patients with extensive stage small cell lung cancer (ES-SCLC). The trial will take place in Greece and aims to gather real-world data on how well this treatment works when given to patients who are starting their first line of treatment. Researchers will collect information from various hospitals across the country, focusing on patients who have been diagnosed with this type of lung cancer and have not received any previous treatment.

To be eligible for this study, participants must be at least 18 years old, have a confirmed diagnosis of extensive stage small cell lung cancer, and should not have previously received any systemic treatment for their cancer. Patients will need to provide their consent to participate, meaning they agree to allow researchers to collect and analyze their medical information related to the study. It’s important to note that the decision to use Durvalumab along with chemotherapy must be made by the doctor before the patient joins the study, ensuring that the treatment plan is not influenced by their participation. Participants can expect to be monitored closely throughout their treatment, and their experiences will help improve understanding of this combination therapy in everyday clinical practice.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female patients, regardless of race (residents in Greece), no younger than 18 years old at the initiation of treatment.
• • Patients with histologically or cytologically confirmed diagnosis of extensive Small Cell Lung Cancer (SCLC)
• • Patients who have not received prior systemic treatment for SCLC (chemotherapy or immunotherapy)
• • Patients for whom the decision to administer treatment with Durvalumab+chemotherapy has already been taken before their inclusion in the study and is clearly separated from the decision of the physician for the patient's participation in the current study.
• • Patients who have provided informed signed consent to participate in the study and to collect and analyze medical data related to the objectives of this study.
• Exclusion Criteria:
• • Patients with current diagnosis of primary cancer other than SCLC who require systemic or other treatment.
• • Patients who have previously received chemotherapy or immunotherapy for SCLC
• • Patients who are currently receiving or are expected to receive treatment with an investigational drug/medical device/intervention or who have received an investigational medicinal product within 1 month or 5 years half-life of the research agent (whichever is longer) before their initiation in this study.