Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide with Durvalumab, Carboplatin, and Etoposide as First-Line Treatment for ES-SCLC (DeLLphi-312)

Résumé de l'étude

This is a Phase III study, which is a late phase in the development process of human medicines. The researchers are examining how effective the treatment with Tarlatamab in combination with Durvalumab, Carboplatin, and Etoposide is compared to a treatment with Durvalumab, Carboplatin, and Etoposide in helping participants live longer. Neither the participants nor the study doctor can choose the combination of study drugs that the participants will receive. Participants agree to be assigned to a treatment group at random. It's like flipping a coin or drawing numbers from a hat. The participants, the study doctor, and the study staff know which study drug the participants will receive.

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Intervention étudiée

The study consists of 2 groups. Participants assigned to Group 1 (experimental group) will receive Tarlatamab, Durvalumab, Carboplatin, and Etoposide. After the initial cycles, only Tarlatamab and Durvalumab will be administered. Participants in Group 2 (control group) will receive Durvalumab, Carboplatin, and Etoposide during the initial treatment cycles. After the initial cycles, only Durvalumab will be administered. Tarlatamab, Durvalumab, Carboplatin, and Etoposide will be given as an intravenous (i.v.) infusion through a tube into a vein. To reduce the likelihood of side effects from Tarlatamab, participants will receive Dexamethasone (or an equivalent dose of another steroid) and intravenous fluids (fluid administration into the vein). These side effects include what is known as cytokine release syndrome (CRS, a sudden severe inflammatory syndrome with symptoms such as fever, chills, low blood oxygen, headaches, low blood pressure, nausea, or vomiting) and immune effector cell-associated neurotoxicity syndrome (ICANS, a condition affecting the brain and nervous system that can occur days to weeks after the administration of Tarlatamab with symptoms of neurological problems such as headaches, speech difficulties, memory loss, seizures, loss of balance or coordination, and tremors of hands and limbs). Participants in both Group 1 and Group 2 will receive a medication to reduce the risk of infection. Additionally, all participants will receive medications to reduce or prevent nausea and vomiting.

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Maladie en cours d'investigation

Extensive-stage small cell lung cancer (ES SCLC) is a condition where cancer cells form in the lung tissue and spread to other parts of the body or lead to a tumor in the lung that is too large for treatment with radiation therapy. This study is being conducted to learn more about Tarlatamab in combination with Durvalumab, Carboplatin, and Etoposide compared to the combination of Durvalumab, Carboplatin, and Etoposide, which is a current standard therapy for untreated individuals with ES SCLC. The study investigates whether the combination of Tarlatamab with the current standard treatment could help people with untreated ES-SCLC live longer. The researchers also want to find out how safe this treatment combination is and whether it causes side effects.

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Sponsor

Amgen Inc., Thousand Oaks, CA, USA Amgen Switzerland AG, Rotkreuz, CH

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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Ethikkommission Ostschweiz EKOS

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Date d'approbation du comité d'éthique

11.09.2025

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Résultats de l'essai