2024 World Conference on Lung Cancer (WCLC) - Posters-P1.13A.01 DeLLphi-306 Trial: A Phase 3 Study of Tarlatamab after Concurrent Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer

P1.13A.01 DeLLphi-306 Trial: A Phase 3 Study of Tarlatamab after Concurrent Chemoradiotherapy in Limited-Stage Small Cell Lung Cancer

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The DeLLphi-306 trial is a Phase 3 clinical study assessing the efficacy and safety of tarlatamab, an innovative bispecific T-cell engager immunotherapy, in patients with limited-stage small cell lung cancer (LS-SCLC) who have completed initial treatment with platinum-based chemotherapy and concurrent radiotherapy without disease progression. The study involves a double-blind, placebo-controlled, randomized design, aiming to determine the effectiveness of tarlatamab in prolonging progression-free survival (PFS) and overall survival (OS) in these patients.<br /><br />The trial follows the promising outcomes of the Phase 2 DeLLphi-301 study, where tarlatamab demonstrated anticancer activity and tolerability, with an objective response rate (ORR) of 40% and a disease control rate (DCR) of 70%. In this current phase, participants receive either a 10 mg dose of tarlatamab or a placebo intravenously over a structured schedule. The trial is being conducted globally, with recruitment sites in the US, Europe, Asia, and Australia.<br /><br />Key inclusion criteria require participants to be 18 years or older, with confirmed LS-SCLC, and having completed chemotherapy and radiotherapy. Exclusion criteria include a history of severe immune-mediated therapy events or prior targeted DLL3 pathway therapy. <br /><br />The study's primary endpoint is progression-free survival as assessed by blinded independent central review, with secondary endpoints including overall survival, disease control rate, and objective response rate. The study design allows for abbreviated outpatient observation following treatment, leveraging the favorable safety profile observed in prior studies.<br /><br />Tarlatamab's mechanism involves directing cytotoxic T cells to attack DLL3-expressing cancer cells, enhancing T-cell mediated cancer cell destruction. The treatment offers potential advancements in the consolidation therapy of LS-SCLC, building on previous accelerated approval for extensive-stage small cell lung cancer by the FDA. The study is sponsored by Amgen Inc., with updates available on ClinicalTrials.gov (NCT06117774).

Asset Subtitle

Afshin Dowlati

Meta Tag

Speaker Afshin Dowlati

Topic SCLC & Neuroendocrine Tumors

Keywords

DeLLphi-306 trial

tarlatamab

bispecific T-cell engager

small cell lung cancer

progression-free survival

overall survival

Phase 3 study

DLL3 pathway

Amgen Inc.

ClinicalTrials.gov