Farrell

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 how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

Researchers are evaluating how sentinel lymph node SLN biopsy surgery compares to standard elective neck dissection END in treating patients with early-stage oral cavity squamous cell carcinoma OCSCC. This phase IIIII trial focuses on patient-reported neck and shoulder function, quality of life, and disease-free survival to determine if SLN biopsy works better or at least as well as the standard surgery while potentially causing less impairment. Participants are randomly assigned to one of two groups. One group receives an imaging agent injection followed by planar imaging and SPECTCT scans over 1 to 2 hours, then undergoes SLN biopsy surgery. The other group undergoes the standard neck dissection surgery. Both groups have FDG PETCT, CT, andor chest x-rays at screening and during follow-up. The trial includes detailed assessments of surgical outcomes, complications, and diagnostic imaging performance. Participants complete patient-reported outcome questionnaires on neck and shoulder function and quality of life before surgery, and at intervals up to 12 months after surgery. Imaging tests and chest x-rays are done at screening and during follow-up visits scheduled at 3 weeks post-surgery, then every 3 months in the first year, every 4 months in the second year, every 6 months in the third year, and annually thereafter. Researchers measure disease-free survival, overall survival, treatment toxicity, and hospital stay length over an extended follow-up of up to 11 years.

Researchers are investigating treatments for patients with metastatic kidney cancer, focusing on whether adding surgery to a standard immunotherapy-based drug combination improves overall survival. This phase III trial compares outcomes for patients receiving immunotherapy with or without surgery to remove the kidney, known as nephrectomy. Immunotherapy drugs like nivolumab, ipilimumab, pembrolizumab, and avelumab aim to help the immune system attack the cancer, while axitinib works to block tumor growth. The benefit of adding surgery to these drug treatments is not yet established. Participants first receive one of three standard immunotherapy-based regimens before randomization, including combinations of intravenous nivolumab, ipilimumab, pembrolizumab, avelumab, and oral axitinib. After about 10 to 14 weeks of this initial treatment, patients are randomly assigned to continue systemic therapy alone or to receive surgery to remove the kidney plus the same systemic therapy. Surgery may be radical or partial and performed using laparoscopic, open, or robotic methods within 8 weeks of randomization. Axitinib is paused before surgery and resumed after recovery. Throughout the study, participants undergo scans and clinical assessments to monitor tumor response and side effects. After completing treatment, patients are followed up every 3 months during the first year, then every 6 months for years two and three, and annually thereafter for up to seven years. The trial measures overall survival, tumor response in metastatic sites, changes in tumor size, and complications from surgery or drug toxicities. Specimens are also collected for future research to better understand the disease and treatments.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating whether high-dose gabapentin can reduce the need for opioid pain medications in patients experiencing mouth sores oral mucositis caused by chemotherapy and radiation treatment for squamous cell carcinoma of the head and neck. Oral mucositis can cause severe pain and complications such as difficulty swallowing, weight loss, feeding tube placement, interruptions in cancer treatment, hospitalizations, and decreased quality of life. Opioids are commonly used to treat this pain but come with significant side effects and risks of long-term use. In this phase III trial, patients are randomly assigned to receive either gabapentin or a placebo starting at radiation treatment day 8. The medication is given orally once daily on day 1, twice daily on day 2, and three times daily from day 3 onward. Both groups also receive standard chemotherapy, radiation, and pain management. Treatment continues until symptoms improve and other pain medications are stopped, followed by a gradual reduction in the study drug dose. Blood samples are collected throughout the study. After treatment, patients are followed for up to 6 months. Participants will have their need for opioids monitored during chemoradiation, along with the time to first opioid use and pain scores assessed up to 4 weeks after treatment ends. Researchers will also explore opioid use duration, symptom and quality of life changes, adverse events, medication tolerance, body weight, kidney function, immune cell counts, and feeding tube requirements. Study visits include regular assessments, blood tests, and questionnaires to gather detailed information on patient outcomes and safety.

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 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.