2023 World Conference on Lung Cancer (Posters)-P2.16. RYZ101 + Carboplatin + Etoposide + Atezolizumab in Somatostatin Receptor Expressing Extensive-Stage Small-Cell Lung Cancer

P2.16. RYZ101 + Carboplatin + Etoposide + Atezolizumab in Somatostatin Receptor Expressing Extensive-Stage Small-Cell Lung Cancer - PDF(Abstract)

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The document discusses a clinical trial in progress for the treatment of somatostatin receptor expressing extensive-stage small-cell lung cancer (ES-SCLC). The trial involves the use of RYZ101, a first-in-class alpha-emitting radiopharmaceutical therapy, in combination with standard of care therapy.<br /><br />RYZ101 is a highly potent therapy that emits alpha-particles, which have a shorter path length and higher energy transfer compared to beta-particles. This potentially allows for higher cancer cell kill rates and less damage to healthy tissues.<br /><br />The trial is a single-arm, open-label, phase 1b dose-escalation and dose-expansion trial. Adult patients with previously untreated SSTR ES-SCLC are eligible for the trial. Patients must have at least one SSTR PET imaging-positive site of disease and sufficient renal, hepatic, and hematologic function.<br /><br />The trial involves dose escalation of RYZ101, starting at 6.5 MBq and potentially escalating up to 10.2 MBq. The recommended phase 2 dose and maximum tolerated dose will be determined based on the occurrence of dose-limiting toxicities.<br /><br />In the dose-expansion phase, patients will receive RYZ101 at the recommended phase 2 dose along with standard of care therapy, including atezolizumab, carboplatin, and etoposide.<br /><br />The primary objectives of the trial are to determine the safety, preliminary antitumor activity, and pharmacokinetics of RYZ101 in combination with standard of care therapy. Efficacy outcomes will be evaluated, including durable objective response rate, duration of response, progression-free survival, and overall survival.<br /><br />The trial will enroll up to 18 patients in the dose-escalation portion. Additional patients may be enrolled in the dose-expansion phase, for a total sample size of 19. Approximately 15 sites in the US will participate in the study.<br /><br />Overall, the trial aims to assess the potential of RYZ101 in improving outcomes for patients with somatostatin receptor expressing extensive-stage small-cell lung cancer.

Asset Subtitle

Claire Mulvey

Meta Tag

Speaker Claire Mulvey

Topic SCLC & Neuroendocrine Tumors: Trials in Progress

Keywords

clinical trial

somatostatin receptor

extensive-stage small-cell lung cancer

RYZ101

alpha-emitting radiopharmaceutical therapy

standard of care therapy

dose-escalation

dose-expansion

pharmacokinetics

objective response rate