A Phase 2 Randomized, Open Label Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 with Atezolizumab Versus Standard of Care in Adults with Untreated Extensive Stage Small Cell Lung Cancer

What this Trial Is About

Small cell lung cancer SCLC is a fast-growing cancer that often spreads early to various parts of the body such as lymph nodes, liver, bones, adrenal glands, and brain. This research is evaluating the safety, dosage, and disease activity changes of an investigational drug called ABBV-706 when given with atezolizumab, compared to the current standard treatment that includes etoposide, carboplatin, atezolizumab, and optionally lurbinectedin. The study is a phase 2 trial involving about 180 adults with untreated extensive stage SCLC. Participants will be randomly assigned to receive one of two doses of ABBV-706 combined with atezolizumab or the standard of care treatment. All treatments are given intravenously and continue until the best ABBV-706 dose is identified. The study includes a safety lead-in phase and an expansion phase, with the entire study lasting up to about 69.5 months. The standard care group may receive etoposide, carboplatin, atezolizumab, and optionally lurbinectedin. During the study, participants will visit hospitals or clinics regularly for medical assessments, blood tests, questionnaires, and scans. Researchers will monitor safety by recording adverse events and evaluate how well the disease is controlled using progression-free survival and response rates over about 24 months. Overall survival will also be assessed. The study will closely track participants health and treatment effects throughout the 69.5-month period.

A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer