Fenton

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating the safety and effectiveness of Halneuron, given as a series of subcutaneous injections, for patients experiencing chemotherapy-induced neuropathic pain CINP. This randomized, double-blind, placebo-controlled Phase 2 study aims to compare Halneuron with placebo injections in managing pain caused by chemotherapy drugs such as platinum and taxane. Participants may have the option to continue in an open-label extension phase where all will receive Halneuron. Participants will be randomly assigned to receive either Halneuron or placebo by subcutaneous injection. After completing the randomized phase, those who choose to continue may enter an open-label extension where every participant receives Halneuron. The study includes careful monitoring during both phases to evaluate the treatments effects and safety. Throughout the study, participants will be closely monitored for pain levels using the Numeric Rating Scale NRS and safety assessments over a four-week period. Additional measurements include patient impressions of change, fatigue, sleep quality, and overall quality of life using standardized questionnaires. The total participation time includes the randomized phase and optional extension, providing ongoing evaluation of Halneurons impact on chemotherapy-induced neuropathic pain.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the benefits and safety of adding sacituzumab tirumotecan to pembrolizumab compared to treatment chosen by a physician in adults with triple-negative breast cancer TNBC who have already received pre-surgery therapy but did not achieve a complete response at surgery. This Phase 3, randomized, open-label trial aims to see if the combination treatment improves invasive disease-free survival compared to current standard options. The study is sponsored by Merck Sharp & Dohme LLC and focuses on patients who need additional therapy after surgery. Participants in one group receive sacituzumab tirumotecan by intravenous infusion every two weeks combined with pembrolizumab every six weeks for a total of 24 weeks. They also receive pre-medication such as antihistamines, H2 antagonists, acetaminophen, and dexamethasone before sacituzumab tirumotecan infusions. The comparison group receives pembrolizumab every six weeks alone or with oral capecitabine twice daily on specific schedules for 24 weeks. The study uses random assignment to these treatment groups and follows participants for long periods. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess invasive disease-free survival for up to about 77 months and track overall survival, recurrence, and quality of life measures for up to around 101 months. Safety will be monitored by recording adverse events and any treatment discontinuations due to side effects. The study includes detailed evaluations of physical functioning, fatigue, and role functioning using questionnaires. Participation lasts several years with ongoing assessments to evaluate long-term outcomes and safety.

Researchers are studying first-line treatment options for participants with non-small cell lung cancer NSCLC in this Phase 23, multisite, randomized, open-label trial. The study includes two substudies based on NSCLC histological subtypes, which have different chemotherapy standards. This design allows evaluation of pumitamig BNT327 combined with chemotherapy and other investigational agents in participants with advanced NSCLC who have not received prior systemic treatment. Participants are randomized to receive one of two dose levels of pumitamig plus chemotherapy during the Phase 2 part of each substudy. In Phase 3, an independent data monitoring committee and a blinded independent central review will oversee safety and tumor assessments. Treatments include pumitamig combined with carboplatin and either pemetrexed or paclitaxel, or pembrolizumab with the same chemotherapies as active comparators. All drugs are given by intravenous infusion. The study period for each participant may last up to 64 months. Throughout the study, participants undergo regular tumor assessments and safety monitoring, including evaluation of adverse events, response rates, progression-free survival, and quality of life using validated questionnaires. Data on dose adjustments and treatment discontinuations are collected. Follow-up continues up to five years to assess long-term outcomes and survival. Participants receive detailed evaluations to understand treatment effects and safety over time in this comprehensive lung cancer trial.