Phase 1b2 Study of Ifinatamab Deruxtecan with Atezolizumab, With or Without Carboplatin, as First-Line Treatment and Maintenance for Extensive Stage Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan I-DXd combined with the immune checkpoint inhibitor atezolizumab, with or without carboplatin, in people newly diagnosed with extensive stage-small cell lung cancer ES-SCLC. This study includes two parts and two groups, aiming to find the best dose and check treatment side effects. The study focuses on first-line treatment and maintenance therapy for this lung cancer type. Participants receive different treatments depending on their group. Some get maintenance therapy with I-DXd and atezolizumab after initial standard treatment, while others receive induction therapy with I-DXd, atezolizumab, and carboplatin followed by maintenance therapy. The dosing varies between 8 mgkg and 12 mgkg of I-DXd, given intravenously every three weeks. The study includes a safety run-in phase and a dose optimization phase, with careful monitoring between dosing of early participants. During the study, participants will have regular visits for treatment administration and safety assessments. Researchers will monitor side effects, treatment responses, and disease progression using imaging scans and clinical evaluations for up to about 37 months. Blood tests will assess drug levels and immune responses. Participants must comply with scheduled visits, biopsies, and laboratory tests. The study aims to understand tolerability, optimal dosing, and effects on cancer control and survival.

A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)