Jangheung

Researchers are assessing the effectiveness and safety of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction GEJ adenocarcinoma whose tumors express PD-L1 CPS 1. The study also evaluates rilvegostomig combined with trastuzumab and chemotherapy to understand the contribution of each treatment component. This is a Phase 2, randomized, open-label, global, multicenter trial sponsored by AstraZeneca. Participants are divided into three groups Arm A receives T-DXd, rilvegostomig, and fluoropyrimidine capecitabine or 5-FU Arm B receives pembrolizumab, trastuzumab, and chemotherapy either 5-FU plus cisplatin or capecitabine plus oxaliplatin Arm C receives rilvegostomig, trastuzumab, and chemotherapy 5-FU plus cisplatin or capecitabine plus oxaliplatin. Treatments are given by intravenous infusion every three weeks or oral administration twice daily for capecitabine. This setup allows comparison of different combinations to evaluate each drugs role. During the study, participants will be monitored for progression-free survival and overall survival up to about six years. Researchers will also assess response rates, duration of response, adverse events, pharmacokinetics, immunogenicity, and quality-of-life factors like eating difficulties and side-effect burden. The study involves regular assessments including tumor measurements and laboratory tests. Participation may last several years, with safety and efficacy closely followed throughout this time.

This research aims to evaluate the safety and effectiveness of Tabrecta4 Capmatinib in patients with non-small-cell lung carcinoma NSCLC who have an exon 14 skipping mutation. The study is observational and open-label, conducted across multiple centers in South Korea to fulfill regulatory requirements set by the Ministry of Food and Drug Safety. It focuses on real-world use of the medication without comparison to other treatments or placebo. Participants will receive Capmatinib prescribed by their treating physician according to the locally approved label. The dose and treatment duration will be determined by the physician under routine clinical practice, with no intervention from the study sponsor regarding these decisions. This post-approval surveillance study does not involve blinding or comparator arms. During the study, participants will be monitored for adverse and serious adverse events from the first dose until up to 28 weeks. Follow-up is recommended for up to 24 weeks or until treatment discontinuation based on clinical judgment. Researchers will assess objective response rates and progression-free survival within 24 weeks. Data collection will continue until the last participant completes the follow-up period.

Researchers are observing the safety and effectiveness of Piqray Alpelisib in patients with advanced breast cancer in Korea. This observational study focuses on patients with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer who have progressed after prior endocrine therapy. The study aims to collect real-world data on Piqray use for up to 24 weeks. Participants prescribed Piqray will be followed during their treatment period, which lasts up to 24 weeks. If a participant stops taking Piqray or misses follow-up visits, all collected data until the last contact will be used. After treatment or early withdrawal, patients will have a safety follow-up for 30 days to monitor any adverse effects. During the study, researchers will collect information about side effects and treatment responses. They will review incidence of adverse events within 24 weeks and measure objective response rates and prescribed doses of Piqray combined with fulvestrant. Participants will be observed through visits and data collection over the treatment and follow-up periods to ensure comprehensive safety and effectiveness monitoring.

Researchers are conducting a post-marketing surveillance study in South Korea to evaluate the safety and effectiveness of iptacopan for treating patients diagnosed with either Paroxysmal Nocturnal Hemoglobinuria PNH or C3 Glomerulopathy C3G. The study collects real-world data from medical records of Korean patients receiving iptacopan under routine clinical care as part of the Risk Management Plan. This observational study aims to understand how iptacopan performs in everyday treatment settings for these conditions. Participants include adults diagnosed with PNH or C3G who have received or will receive iptacopan according to the approved Korean labeling. The study monitors two patient groups those treated for PNH and those treated for C3G. Patients must have received recommended vaccinations before starting iptacopan. Treatment is not assigned by the study but follows routine medical practice, and all dosing and administration decisions are made by the treating physicians. During the study, researchers collect data on adverse events and drug reactions over up to two years. Laboratory measurements such as hemoglobin, lactate dehydrogenase, blood cell counts, kidney function tests, and urine protein levels are collected at the start and at 24 weeks to assess changes. Investigators also evaluate overall patient improvement at 24 weeks. Participants provide informed consent, and their health information from medical records is used to assess treatment outcomes and safety in routine clinical care.

Researchers are evaluating the combination of Surovatamig AZD0486, a fully human bispecific monoclonal IgG4 antibody, plus rituximab versus standard immunochemotherapy regimens in adults with untreated follicular lymphoma FL. This global, randomized, open-label Phase III study aims to assess the efficacy, safety, and added benefit of this combination compared to investigator-chosen standard treatments. The study includes a safety run-in and a Phase III portion with three treatment arms. The study has two parts first, a Safety Run-in to determine the recommended Phase III dose RP3D of Surovatamig combined with rituximab second, a Phase III comparison of Surovatamig plus rituximab two dosing schedules against one of three standard chemoimmunotherapy regimens chosen by the investigator R-CVP, R-CHOP, or B-R, all followed by rituximab maintenance. Participants are assigned to one of these three arms to evaluate treatment effects. Participants will be monitored for up to 10 years, with assessments including adverse event tracking, dose adjustments, and efficacy measures such as response rates, progression-free survival, and overall survival. Evaluations involve physical exams, laboratory tests, and imaging to measure disease activity and safety. The study aims to gather long-term data on treatment impact and safety in this patient population.

Researchers are evaluating the safety and effectiveness of Asciminib in Korean patients with Chronic Myeloid Leukemia CML in a prospective, open-label, multi-center observational study. The study focuses on understanding how Asciminib works in real-world clinical settings following its market approval, enrolling patients treated under usual clinical practice. Participants prescribed Asciminib by their physicians according to the locally approved label will be included in this study. The dosage and duration of Asciminib treatment will be decided by the investigators based on prescribing information. The study plans to enroll all patients prescribed Asciminib for two years after its market launch. During the study, researchers will monitor participants for adverse events and various molecular response rates at 12 and 24 weeks. Data on safety, including serious and unexpected adverse reactions, will be collected. Participants will be followed during their usual care, and no study drug will be dispensed by the sponsor. The total participation duration depends on clinical practice and monitoring schedules.

This research evaluates the long-term safety of asciminib treatment in patients with Philadelphia chromosome-positive chronic myelogenous leukemia CML or acute lymphoblastic leukemia ALL who have completed a prior Novartis-sponsored asciminib study. It is designed to provide continued treatment for participants who, as judged by their investigator, would benefit from ongoing therapy but cannot access it outside the trial. This open-label, multi-center, global roll-over study focuses on assessing safety over an extended period. Participants receive asciminib or other related drugs such as imatinib, nilotinib, bosutinib, or dasatinib, either alone or in combination, based on their previous study treatments. Dosing varies with the specific drug for example, asciminib is taken orally once or twice daily, sometimes in fasting state, and pediatric participants receive a body weight-adjusted dose of asciminib granules. The study includes groups continuing their previous treatment, some switching from bosutinib or dasatinib to asciminib, and combinations with other tyrosine kinase inhibitors. Participants are monitored for adverse events and serious adverse events over eight years as the primary safety outcome. Secondary outcomes include clinical benefit assessments by investigators. During the study, participants undergo scheduled visits, treatment adherence tracking, and safety monitoring. The study spans from August 2022 to August 2030, allowing long-term observation of treatment effects and safety in this patient population.

Researchers are studying the long-term safety, risk of secondary cancers, and effectiveness of tisagenlecleucel in patients with B-cell malignancies treated in routine clinical practice in South Korea. This observational registry study collects primary data from multiple centers and follows participants for up to 15 years after receiving the treatment. The focus is on real-world outcomes to better understand the long-term effects of tisagenlecleucel in these patients. Participants included in this study have already been treated with tisagenlecleucel, and there is no new treatment given as part of the trial. The study observes patients who have received this therapy through commercial, managed access, or other pathways. No treatment allocation occurs since this is a non-interventional study, and the decision to use tisagenlecleucel is based on clinical judgment outside of the study protocol. During the 15-year follow-up, researchers will monitor participants for adverse events, secondary malignancies, and the presence of lentivirus in blood or tissues. They will assess long-term effectiveness outcomes such as response rates, duration of response, relapse-free and progression-free survival, and overall survival for different B-cell malignancies. Data collection includes safety monitoring and pregnancy outcomes. This extended observation aims to provide comprehensive information on the long-term impact of tisagenlecleucel treatment.

This research aims to observe the safety and effectiveness of Pluvicto in adult male patients with metastatic castration-resistant prostate cancer mCRPC in South Korea. It is an open-label, multi-center, non-comparative, and non-interventional observational study conducted in real-world clinical settings. The study focuses on collecting primary data without altering standard patient care. Participants in this study include male adults aged 18 to 100 who are prescribed Lutetium vipivotide tetraxetan Pluvicto based on clinical judgment by their physicians. There is no randomization or treatment allocation, as the study observes patients already scheduled or currently receiving Pluvicto. The study does not interfere with treatment decisions but collects information during routine care. During the study, researchers will monitor and record adverse events and drug reactions up to 30 days after the last Pluvicto dose, spanning up to 33 months. They will also assess the objective response rate about four weeks after the last dose and follow radiographic progression-free survival for up to 33 months. Participants will undergo regular assessments during treatment and follow-up periods to track safety and effectiveness outcomes.