Fairfield

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating NX-5948 bexobrutideg in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with both a Brutons Tyrosine Kinase BTK inhibitor and a B-cell lymphoma-2 BCL-2 inhibitor. This study aims to understand how well NX-5948 works as a treatment by destroying the BTK protein, which differs from BTK inhibitors that only block part of its activity. The study also assesses the safety of NX-5948 and its presence in the bloodstream over time. Participants will receive NX-5948 orally once daily in continuous 28-day cycles until their cancer worsens or other reasons require stopping treatment. During treatment, patients will have regular check-ups to monitor their cancer and overall health. If a patients cancer has not progressed and they stop taking NX-5948, they will continue to have cancer evaluations until progression occurs. Participation could last up to five years or longer if the disease remains stable. Throughout the study, researchers will measure the objective response rate without partial response with lymphocytosis, along with other outcomes like duration of response, progression-free survival, overall survival, quality of life, and safety through adverse event monitoring and laboratory tests. Assessments include regular health check-ups, quality of life questionnaires, and blood tests. The study is open-label and involves ongoing evaluation of the drugs effects and participant well-being for up to five years.

Small cell lung cancer SCLC is a fast-growing and aggressive cancer that often spreads early to areas such as lymph nodes, liver, bones, adrenal glands, and brain. This trial is assessing the safety, tolerability, and changes in disease activity of an investigational drug called ABBV-706 compared to standard treatments including topotecan, lurbinectedin, or amrubicin. The study is a Phase 3 randomized trial involving adults with relapsed or refractory SCLC who have received prior therapy. Participants in this study are randomly assigned to receive either intravenous ABBV-706 or one of the standard care treatments topotecan, given intravenously or orally lurbinectedin intravenously or amrubicin intravenously. The study duration is approximately 53 months, with treatments and assessments occurring during this period. The trial is conducted across multiple sites worldwide. During the study, participants will have regular visits to hospitals or clinics for various medical assessments including blood tests, scans, and questionnaires to monitor their health and disease status. Researchers will measure outcomes such as tumor response, overall survival, progression-free survival, duration of response, and quality of life changes. Safety and adverse events will also be monitored throughout the trial period.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

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 reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are evaluating a combination of quaratusugene ozeplasmid and atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer ES-SCLC who have not experienced tumor progression after initial chemotherapy and immunotherapy. This study includes two phases Phase 1, which focused on selecting the appropriate dose, and Phase 2, which is assessing safety and effectiveness at the recommended dose. In Phase 1, patients received quaratusugene ozeplasmid intravenously every 21 days at varying doses alongside atezolizumab, also given intravenously every 21 days, until disease progression or unacceptable side effects occurred. Phase 2 continues treatment at the determined recommended dose of quaratusugene ozeplasmid combined with atezolizumab, with some patients also receiving hyaluronidase-tqjs subcutaneously every 21 days. Participants will be monitored through regular assessments including evaluation of side effects using standardized criteria, pharmacokinetic studies, and survival tracking. The main outcomes include identifying the appropriate dose and measuring progression-free survival over 18 weeks. Safety and overall survival will also be followed for months after treatment initiation, with treatment continuing until disease progression or unacceptable toxicity. Total participation duration varies based on individual treatment response and study phase.

Researchers are evaluating how well radiation therapy with or without the chemotherapy drug cisplatin works in treating patients who have stage III-IVA squamous cell carcinoma of the head and neck after surgery. This phase II trial aims to understand if adding cisplatin to radiation therapy improves disease-free survival and to explore the role of p53 mutations as a biomarker for treatment benefit. The study also assesses the safety and side effects of these treatments and looks for other genetic changes that might guide new therapies. Participants are randomly assigned to one of two groups. One group receives intensity-modulated radiation therapy IMRT once daily, five days a week for six weeks. The other group receives the same radiation schedule plus weekly intravenous cisplatin for six weeks. After treatment, participants are followed up every six months for three years and then yearly for seven years to monitor outcomes. During the study, patients will have assessments including surgical tumor tissue analysis for p53 mutation, imaging scans to check for cancer spread, and blood tests to monitor health and organ function. Researchers will track disease recurrence, new tumors, or death for up to 10 years. Side effects will be recorded during treatment. The total study participation includes treatment over six weeks followed by long-term follow-up visits lasting up to 10 years.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.