An open, randomized, multicenter phase II study with different Tarlatamab dosing regimens in individuals with SCLC

Résumé de l'étude

This is a phase 2 study, the second stage in the development process of human medicines. The researchers want to investigate the efficacy and safety and find out if this study drug could help participants with SCLC. The participants, the principal investigator, and the study staff know what dosage each participant receives. Participants are randomly assigned, like flipping a coin, to one of 3 groups. This means that the probability of being assigned to one of the groups is equal. The study lasts for participants for up to about 52 months. This includes a pre-screening phase of up to 21 days, a treatment phase whose duration depends on how the disease responds and how well the body tolerates Tarlatamab, a safety follow-up appointment, and a long-term follow-up, which occurs by phone, in the form of appointments at the study center, or by reviewing medical records and may last up to 3 years after the last participant is enrolled.

(BASEC)

Intervention étudiée

Participants receive Tarlatamab as an infusion [a plastic tube inserted into a blood vessel (usually a vein in the arm)] at different administration intervals depending on the group they are assigned to. Participants also receive Dexamethasone (or comparable doses of other corticosteroids) and 1 l of saline solution to reduce the risks associated with Tarlatamab. All participants will be monitored after the first 2 doses. Depending on the dose group, monitoring after the third dose may also be required. Participants will be discharged at the discretion of the principal investigator if there are no signs and symptoms of CRS (cytokine release syndrome: sudden and severe release of inflammatory proteins with symptoms such as fever, chills, low blood oxygen, headache, low blood pressure, nausea, or vomiting) or other abnormalities. Monitoring is not required at subsequent visits but may be recommended by the principal investigator if side effects such as CRS or ICANS (immune effector cell-associated neurotoxicity syndrome: a disease of the brain and nervous system that can occur days to weeks after Tarlatamab administration and lead to symptoms of neurological problems such as headaches, speech difficulties, memory loss, seizures, loss of balance or coordination, and tremors of the hands and limbs) occur.

(BASEC)

Maladie en cours d'investigation

Small cell lung cancer (SCLC) is a condition in which cancer cells proliferate in lung tissue and may spread to other parts of the body. This study is being conducted to learn more about Tarlatamab in individuals with SCLC whose disease has progressed after platinum-based chemotherapy (a type of cancer treatment with drugs that contain platinum ions). The study investigates how well different doses and administration schedules of Tarlatamab work and whether they cause side effects.

(BASEC)

Sponsor

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

(BASEC)

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

Commission cantonale de Zurich

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Date d'approbation du comité d'éthique

17.01.2025

(BASEC)

Résultats de l'essai