Osakasayama

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

Researchers are investigating the effectiveness and safety of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as first-line treatment for recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma HNSCC. This Phase 3 randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease and aims to improve treatment outcomes in this population. Participants will be randomly assigned to receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone. The study excludes patients previously treated with anti PD-L1 or anti-EGFR therapies, with some exceptions for local treatments like cetuximab under specific conditions. The treatments will be administered as part of the trial, with researchers comparing the two approaches over the treatment period. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, health-related quality of life questionnaires, and safety monitoring for adverse events. The main outcomes measured include overall survival and objective response rate up to approximately three years. Additional assessments include progression-free survival, duration of response, and pharmacokinetics. These activities aim to provide comprehensive data on how well the treatments work and their safety profiles throughout the study period.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

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.

Researchers are evaluating ASP3082, a drug given by intravenous infusion, in adults with advanced or metastatic solid tumors that have a specific mutation called KRAS G12D. This open-label Phase 1 study aims to check the safety and tolerability of ASP3082 alone or combined with other treatments like cetuximab, FOLFIRINOX, Nab-Paclitaxel plus gemcitabine, docetaxel, pembrolizumab, platinum-based chemotherapy, and NALIRIFOX. Participants have tumors that have not responded to or are ineligible for standard therapies. The study consists of two parts. In Part 1, small groups of participants receive escalating doses of ASP3082 alone or with cetuximab to find suitable doses. In Part 2, participants receive ASP3082 alone or combined with other study treatments at doses selected from Part 1. Treatments are given by infusion in cycles of 21 or 28 days. Participants continue treatment until intolerable side effects, disease progression, start of other cancer therapy, or withdrawal. Throughout the study, participants undergo regular monitoring for side effects, physical exams, lab tests, ECGs, and assessments of tumor response using standard criteria. Safety is tracked up to 48 months. Researchers collect tumor samples before and during treatment to study changes in the KRAS mutation. Participants overall health and performance status are also evaluated during the study, which may last several years depending on individual outcomes and treatment responses.

Researchers are evaluating BH-30643, a new oral drug designed to treat patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have specific mutations in the EGFR andor HER2 genes. This Phase 12 open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor effects of BH-30643. The study will focus on patients with a variety of EGFR mutations, including common and atypical ones, and those resistant to previous treatments. In Phase 1, participants receive BH-30643 either alone or combined with chemotherapy drugs Carboplatin and Pemetrexed, with doses gradually increased to find the best dose for further study. Phase 2 will further explore the drugs effectiveness and safety at the recommended dose in groups defined by their mutation type or treatment history. BH-30643 is taken orally as capsules or tablets, and chemotherapy is given following standard care when combined. Participants will undergo regular assessments including scans to measure tumor size, blood tests to monitor drug levels and safety, and questionnaires about symptoms and quality of life. The study monitors side effects from the start through completion, which may last up to about four years. Researchers will measure outcomes like dose-limiting toxicities, tumor response rates, progression-free survival, and overall survival to understand how the treatment works over time.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan I-DXd combined with the immune checkpoint inhibitor atezolizumab, with or without carboplatin, in people newly diagnosed with extensive stage-small cell lung cancer ES-SCLC. This study includes two parts and two groups, aiming to find the best dose and check treatment side effects. The study focuses on first-line treatment and maintenance therapy for this lung cancer type. Participants receive different treatments depending on their group. Some get maintenance therapy with I-DXd and atezolizumab after initial standard treatment, while others receive induction therapy with I-DXd, atezolizumab, and carboplatin followed by maintenance therapy. The dosing varies between 8 mgkg and 12 mgkg of I-DXd, given intravenously every three weeks. The study includes a safety run-in phase and a dose optimization phase, with careful monitoring between dosing of early participants. During the study, participants will have regular visits for treatment administration and safety assessments. Researchers will monitor side effects, treatment responses, and disease progression using imaging scans and clinical evaluations for up to about 37 months. Blood tests will assess drug levels and immune responses. Participants must comply with scheduled visits, biopsies, and laboratory tests. The study aims to understand tolerability, optimal dosing, and effects on cancer control and survival.