West Islip

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 II/III 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 collecting samples and information from patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) who will receive standard neoadjuvant chemotherapy with either FOLFIRINOX or Gemcitabine plus Nab-paclitaxel. The study aims to find blood or tumor biomarkers that could help predict how patients respond to these treatments and guide future therapy choices. This observational research focuses on patients with borderline resectable or resectable PDAC according to National Comprehensive Cancer Network criteria. Participants will undergo standard care chemotherapy and provide blood samples and archival tumor tissue for biomarker analysis. The study follows two groups: patients with borderline resectable disease and those with resectable disease. Researchers will compare the pathological response to treatment in these groups and assess biomarkers retrospectively to evaluate their potential to predict complete pathological response. During the study, patients' survival status and tumor response will be monitored for up to two years. Researchers will collect and analyze data including blood samples, tumor tissue, and clinical outcomes using RECIST 1.1 criteria. The study involves informed consent and requires participants to have good performance status. This observational study does not involve experimental treatment but focuses on gathering data to improve future treatment selection.

Researchers are studying an early intervention led by an oncology clinical nurse specialist that uses a multidisciplinary approach to palliative and survivorship care for adults with metastatic solid tumor malignancies. This randomized control trial aims to compare this nurse-led care model to the standard palliative care approach, focusing on patient-reported symptom burden, overall quality of life, distress, and overall survival. The study targets patients in favorable and very favorable risk groups to evaluate the impact on symptoms like pain, tiredness, nausea, depression, anxiety, and wellbeing. Participants will be assigned randomly to either the nurse-specialist-led intervention or the standard care group. The intervention group receives usual care plus additional coordinated services, patient education, referrals, and ongoing support from the oncology nurse-specialist, including in-person visits and scheduled telephone follow-ups. The standard care group follows usual clinical guidelines with physician and nursing visits scheduled typically at 3, 9, 15, and 24 months. Both groups will complete surveys at multiple timepoints to assess symptoms and quality of life throughout the study period. During the 24-month study, participants will complete validated questionnaires to report symptoms, distress, and quality of life, supported by nursing staff. Data collection occurs at six timepoints using brief surveys that take about 5-6 minutes each. The research team will monitor safety regularly, tracking any adverse events. Survival data will be followed for up to 60 months. Participants can withdraw at any time without affecting their medical care. Total survey time is about 50 minutes for standard care and 85 minutes for the intervention group over 24 months.

Researchers are evaluating how doctors use the Percepta4 Nasal Swab test results to manage patients with newly found pulmonary nodules. This observational study aims to see if the test helps reduce invasive procedures in patients with low-risk benign nodules and speeds up treatment for those with high-risk cancerous nodules. The study is prospective, multicenter, and randomized, involving patients whose nodules were found incidentally or through lung cancer screening. Participants will be randomly assigned to two groups: one where the Percepta Nasal Swab test result is given to the physician and one where it is not. The study will compare how doctors manage patients' nodules with and without access to the test result. About 2400 participants will be enrolled across up to 100 US centers, with enrollment lasting around 24 months. Follow-up will continue for 24 to 30 months or until a lung cancer diagnosis. During the study, researchers will track the number of invasive diagnostic procedures from randomization until the nodule is confirmed benign or stable for up to 30 months. They will also measure the time from randomization to the start of lung cancer treatment. Participants will undergo nasal specimen collection, and clinical history and imaging data will be reviewed. The study observes routine care decisions influenced by the test, without altering standard treatment plans.

Researchers are evaluating whether adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups: one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigator’s discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients’ health and quality of life.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points: at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase II/III 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 study's 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 a connected customized treatment platform called CONCURxP to improve medication adherence in patients with metastatic breast cancer who are taking CDK4/6 inhibitors. The study compares CONCURxP, which combines a medication monitoring device called WiseBag with personalized text reminders and healthcare provider follow-ups, against enhanced usual care where patients only use the WiseBag with access to educational materials. The goal is to see if these tools help patients follow their complex treatment schedules better, as forgetfulness is a common cause of missed doses. Participants are assigned randomly to one of two patient groups or a non-patient interview group. In Arm A, patients use the WiseBag dispenser and receive educational materials every four weeks for 12 months. In Arm B, patients use the WiseBag and receive personalized text message reminders, medication tracking, and healthcare provider follow-ups through the CONCURxP platform over 12 months. Those in Arm B may also complete a 20-30 minute interview within six months after finishing the study. Arm C involves non-patient participants completing an interview 15 to 39 months after the first patient enrolls. After completing the study interventions, patients may be followed for up to six additional months. During the study, researchers monitor medication adherence using electronic tracking and self-reports at multiple points up to 12 months. They also assess symptom burden, quality of life, patient-provider communication, self-efficacy in managing symptoms, and financial worry through surveys. Additional measures include healthcare use, progression-free survival, and overall survival at 12 months. Interviews with patients and providers in Arm B explore experiences with the CONCURxP platform. This comprehensive approach helps understand the impact of digital tools on treatment adherence and patient well-being while ensuring continuous monitoring and support throughout the year-long study.

Researchers are evaluating the combination of bevacizumab and osimertinib versus osimertinib alone as an initial treatment for patients with advanced non-small cell lung cancer (NSCLC) that has spread beyond the lungs and has specific mutations in the EGFR gene. This phase III trial aims to understand if adding bevacizumab, which inhibits blood vessel growth to tumors, can control cancer longer and improve survival compared to osimertinib alone, which blocks EGFR involved in tumor cell growth. Participants are randomly assigned to one of two groups. One group receives daily oral osimertinib every 21 days, while the other group receives the same osimertinib dose plus an intravenous bevacizumab infusion every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, patients undergo various imaging tests such as echocardiography, multigated acquisition scan, computed tomography, and possibly magnetic resonance imaging, along with blood and urine sample collections. After treatment ends, patients are followed every three months for up to 10 years to monitor their health and disease status. The main outcome measured is progression-free survival, tracking the time until the cancer worsens or death occurs. Secondary outcomes include overall survival, response rates, and effects on central nervous system progression. Safety is also assessed through adverse event monitoring. This long-term follow-up helps researchers understand the lasting effects of the treatments.