Study on Durvalumab with or without Tremelimumab and Chemotherapy for Untreated Extensive-Stage Small Cell Lung Cancer

Program Overview

The purpose of this study is to find out if adding the drugs durvalumab and tremelimumab to standard chemotherapy can improve treatment outcomes for patients with extensive-stage small cell lung cancer (SCLC). The study will compare three groups: one receiving durvalumab and tremelimumab with chemotherapy, another receiving durvalumab with chemotherapy, and a third receiving only chemotherapy. Researchers will monitor patients to see how well the treatments work and how safe they are.

Description

This study aims to evaluate how well the combination of durvalumab and tremelimumab with chemotherapy works compared to chemotherapy alone in treating extensive-stage small cell lung cancer (SCLC). Patients will be randomly assigned to one of three groups:

• Group 1 will receive durvalumab, tremelimumab, and chemotherapy.
• Group 2 will receive durvalumab and chemotherapy.
• Group 3 will receive only chemotherapy, which is the standard treatment.

Patients in Groups 1 and 2 will continue treatment until their cancer progresses, while those in Group 3 will receive up to 6 cycles of chemotherapy and possibly preventive brain radiation if needed. All patients will be monitored for cancer progression and survival.

The study is open to adults aged 18 and older with extensive-stage SCLC, who are in good overall health and have not received prior immune therapy. Tumor assessments will be conducted at the start of the study, at 6 weeks, 12 weeks, and then every 8 weeks until the cancer progresses. An independent committee will review the safety of the treatments during the study.

Eligibility Criteria

Locations