Leavenworth

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Researchers are evaluating whether adding chemotherapy to immunotherapy with pembrolizumab improves overall survival compared to pembrolizumab alone in older adults with advanced non-small cell lung cancer NSCLC stages IIIB-IV. This phase III trial focuses on patients aged 70 and above with tumors expressing PD-L1 at 1-49 and without certain genetic mutations. The study aims to assess survival, progression-free survival, response rates, toxicity, and quality of life in this vulnerable population. Participants are randomized into two groups. One group receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. The other group receives pembrolizumab plus a chemotherapy regimen chosen by the investigator, given intravenously on specific schedules repeating every 21 days for four cycles, followed by the same pembrolizumab maintenance. Imaging with MRI, CT, andor PET scans is performed at baseline and throughout the trial. During the trial, patients undergo regular evaluations including imaging studies, laboratory tests, and quality of life questionnaires. Follow-up visits occur every three months for up to two years after treatment and then every six months up to five years. Researchers measure overall survival, disease progression, treatment response, adverse events, and patient-reported quality of life. The study also explores safety, tolerability, geriatric assessments, and correlations between gut microbes and outcomes.

Researchers are collecting blood and tissue samples from patients with and without cancer to evaluate tests that might help detect cancer early. This observational study aims to create a blinded reference set of blood samples from both cancer and non-cancer patients to validate blood-based multi-cancer early detection tests. The study also assesses test performance at the time of initial cancer diagnosis by tumor type and clinical stage. Participants complete a questionnaire at the start of the study and provide blood samples at registration and again 12 months later. Patients diagnosed with cancer may also provide tissue samples at these same time points. The study collects samples to support the development and validation of early detection assays, with no treatment interventions involved. During the study, participants fill out questionnaires and provide blood and possibly tissue samples. Researchers follow up with participants one year after study completion. The main outcome is the creation of a blinded reference set of blood samples to test early cancer detection methods. The study monitors test performance based on cancer type and stage, with all evaluations completed within one year of enrollment.

Researchers are comparing two monoclonal antibody treatments, rituximab and mosunetuzumab, for patients with follicular lymphoma who have a low tumor burden and have not received prior systemic therapy. The study aims to evaluate which treatment provides better progression-free survival and overall outcomes. This phase III randomized clinical trial also assesses overall survival, response rates, event-free survival, and treatment-related toxicities over time. Participants are randomly assigned to receive either rituximab or mosunetuzumab. Those in the rituximab group receive intravenous rituximab on day 1 of the first cycle and subcutaneous rituximab with hyaluronidase on several days, repeating every 56 days for up to five cycles if tolerated. The mosunetuzumab group receives the drug subcutaneously on specified days every 21 days for up to eight cycles. During treatment, patients undergo CT andor PETCT scans and blood sample collections to monitor disease and health. After completing treatment, participants are followed every six months for five years, then annually up to a total of ten years. The study includes regular imaging and blood tests to assess disease progression, response, and safety. The main outcomes measured are progression-free survival milestones, with other key measures including overall survival and adverse events. Specimens are also collected for future research to better understand the disease and treatment effects.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication LSS with NC in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression IPD. The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the studys NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating zanubrutinib treatment approaches for older adults with mantle cell lymphoma MCL who have not been treated before. This phase III trial compares continuous versus intermittent zanubrutinib after patients achieve complete remission with initial zanubrutinib plus rituximab therapy. The study aims to find out if stopping zanubrutinib until disease progression is as safe and effective as continuing it indefinitely, which could reduce treatment and financial burdens for older patients. Participants first receive induction therapy combining oral zanubrutinib and intravenous rituximab, along with bone marrow biopsies and imaging scans such as PETCT or CT. Those who achieve complete remission are then randomly assigned to one of two maintenance treatments continuous zanubrutinib until disease progression, or observation until progression followed by zanubrutinib restarted until second progression. Optional blood sample collection and additional procedures like endoscopy may be performed when needed. Throughout the trial, patients undergo regular imaging CT, MRI, or PETCT and laboratory assessments to monitor their response and safety. Researchers measure progression-free survival, overall survival, response rates, adverse events, and quality of life using validated questionnaires. After treatment ends, participants are followed for up to 10 years with visits every six months to assess long-term outcomes and health status.