Mount Waverley

This research aims to evaluate the effectiveness and safety of zanidatamab combined with a physicians choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer who have either progressed on or cannot tolerate previous trastuzumab deruxtecan T-DXd treatment. Zanidatamab has shown promising results against various HER2-positive advanced tumors, including metastatic breast cancer, and may serve as a potential treatment option for these patients. The study also investigates patient-reported tolerability and physical functioning, as well as the pharmacokinetics and immune response to zanidatamab with chemotherapy. Participants will be randomly assigned to receive either zanidatamab or trastuzumab, each given by intravenous infusion alongside one of several chemotherapy options chosen by the physician eribulin, vinorelbine, gemcitabine, or capecitabine the latter is taken orally. Treatment will be administered according to the assigned group, and the study is open-label and multicenter, designed to compare these two treatment combinations in this patient population. During the study, participants will undergo regular assessments to monitor disease progression using imaging criteria RECIST version 1.1, evaluate survival, treatment response, and duration of response. Safety and side effects will be tracked through adverse event reporting and patient questionnaires on symptoms and physical function. Blood samples will be collected to study drug levels and immune reactions. Participants will be followed until disease progression, death, or for up to approximately 44 months for key outcomes, with overall survival monitored for up to about 80 months.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

Researchers are establishing the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer IRONMAN as a prospective, global group of at least 5,000 men with advanced prostate cancer, including those with metastatic hormone-sensitive prostate cancer mHSPC and metastatic castration-resistant prostate cancer M0M1 CRPC. This study aims to better understand variations in care and treatment across different countries and medical settings by collecting detailed patient data over time. Participants will receive standard care drugs routinely used for metastatic prostate cancer based on local practices. Data collection begins at enrollment and continues for at least five years. Blood samples and tumor tissue, when possible, will be collected at enrollment, treatment changes, and follow-ups to study molecular markers linked to treatment response and resistance. Patient-reported outcome measures PROMs will be gathered every three months, and physicians will provide treatment and follow-up information regularly. During the study, participants will provide health and treatment information through questionnaires, with regular monitoring of survival, adverse events, and comorbidities. Blood samples will support future research to identify biomarkers. The main outcome is observing practice patterns over five years to help improve understanding of treatment sequences that optimize survival and quality of life for men with advanced prostate cancer.