Small cell lung cancer metastatic Trials in Disease

Study of Durvalumab, Cisplatin, Carboplatin, and Etoposide for Patients with Extensive Stage Small Cell Lung Cancer

This clinical trial is being conducted in Germany and focuses on patients with extensive stage small cell lung cancer that has spread to other parts of the body. The study combines several different treatment approaches to test whether this combination can help patients live longer without their cancer getting worse.

Main inclusion criteria:

• Patients must have a first diagnosis of extensive stage disease, confirmed by a tissue sample test
• The cancer must be oligometastatic, meaning there is a primary tumor and up to four distant tumor sites that can be treated with specialized radiation therapy
• Patients must have had stable disease or partial response after two cycles of platinum-based chemotherapy combined with etoposide and durvalumab
• Patients must be able to carry out normal activities or at least light work, as measured by an ECOG performance status of 0 or 1
• Life expectancy must be at least 12 weeks
• Both male and female adult patients can participate

Main exclusion criteria:

• Patients with any other type of cancer besides small cell lung cancer
• Previous treatments that might interfere with the study treatment
• Serious health conditions that could make the treatment unsafe
• Pregnancy or breastfeeding
• Known allergies to the study medications
• Current participation in another clinical trial
• Inability to follow study procedures or attend required visits

Focus and goal of the trial:

The trial tests a comprehensive treatment plan that begins with a combination of chemotherapy medications delivered through an infusion into the bloodstream. This initial phase is followed by thoracic radiotherapy, which targets the chest area. Patients then receive stereotactic radiotherapy, a highly precise form of radiation that focuses on specific tumor sites. After completing these phases, patients continue with maintenance therapy using durvalumab to help prevent the cancer from returning. The main goal is to see if this combination approach can improve progression-free survival at 12 months, meaning patients can live longer without their disease worsening. The trial also aims to evaluate patient quality of life and overall survival rates. Recruitment began in 2024, with the study expected to continue until 2026.

Investigational drugs:

The trial uses several medications working together:

• Durvalumab is an immunotherapy that helps the immune system recognize and attack cancer cells more effectively. It works by blocking a protein called PD-L1, which cancer cells use to hide from the immune system. In this trial, durvalumab is used both during initial treatment and as maintenance therapy afterward
• Platinum-based chemotherapy (cisplatin and carboplatin) are medications that damage the DNA of cancer cells, preventing them from dividing and growing
• Etoposide is a chemotherapy drug that interferes with cancer cell DNA to stop cells from dividing and spreading

All medications are given as infusions directly into the bloodstream in a hospital or clinical setting, with dosages tailored to each patient's specific condition and response to treatment.