Northwestern Medicine Orland Park

This research aims to evaluate how well amivantamab given by subcutaneous injection works in treating patients with advanced non-small cell lung cancer that has extra copies of the MET gene. This phase II Expanded Lung-MAP treatment trial focuses on patients with MET amplification-positive non-small cell lung cancer. The goal is to see if amivantamab-SC can reduce tumor growth or spread by targeting the extra MET gene copies in these tumors. Participants receive amivantamab subcutaneously on days 1, 8, 15, and 22 during the first 28-day cycle, then on days 1 and 15 of subsequent 28-day cycles as long as the disease does not progress or unacceptable side effects occur. Throughout the trial, patients have regular CT or MRI scans and blood samples taken to monitor treatment effects and disease status. After completing treatment, patients are followed for up to 3 years to assess long-term outcomes. During the study, researchers evaluate how many patients respond to the treatment, how long responses last, progression-free survival, overall survival, and the frequency and severity of side effects. Blood samples are collected before treatment, during therapy, and at disease progression to study tumor DNA and build a tissue and blood repository. Safety labs, physical exams, and performance status assessments are also conducted. The total participation can last up to 3 years including follow-up.

Researchers are investigating targeted therapies directed by genetic testing for patients with locally advanced or advanced solid tumors that have spread or progressed after standard treatments. This Phase 2 screening trial, called ComboMATCH, aims to match patients to specific combination treatments based on genetic mutations found in their tumor cells. The study seeks to improve treatment planning by using genetic information to guide therapy choices. Patients undergo tumor genetic screening using previously collected samples or a new biopsy if eligible and aged 18 or older. Based on their tumors genetic profile, patients are assigned to one of multiple treatment subprotocols involving different drug combinations. Treatments include oral, intravenous, and intramuscular drugs such as selumetinib, olaparib, fulvestrant, binimetinib, and others. Treatment cycles generally repeat every 28 days until disease progression or unacceptable toxicity. Patients may also undergo biopsies, blood collection, imaging scans CT, MRI, PET, echocardiograms, and bone marrow procedures as part of the study. Throughout the trial, participants have regular assessments including tumor biopsies, blood draws, imaging tests, and heart function monitoring. These evaluations occur during screening, treatment, and follow-up periods. Researchers measure patient enrollment, assignment to treatment arms, and treatment outcomes over up to 8 years. Safety is monitored via clinical evaluations and diagnostic tests. This comprehensive approach aims to evaluate responses to targeted therapies guided by tumor genetics for advanced solid tumors.

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 effect of adding the drug tivozanib to the immunotherapy pembrolizumab compared to pembrolizumab alone in patients with high-risk renal cell carcinoma RCC. The study aims to determine whether this combination improves disease-free survival and overall survival. This phase III trial also assesses side effects, quality of life, and collects specimens for future research in patients who have undergone surgery to remove all known kidney cancer sites. In this study, participants are randomly assigned to one of two groups. One group receives pembrolizumab intravenously on specific days of each 12-week cycle for up to 4 cycles. The other group receives the same pembrolizumab schedule combined with oral tivozanib taken daily on specific days within the 12-week cycle for up to 6 months. Throughout the trial, participants undergo blood samples, MRI or CT scans, and may have tissue biopsies. After treatment, patients are followed regularly for up to 10 years to monitor outcomes. Participants will have scheduled visits during treatment cycles and follow-up visits every 4 months for 2 years, then every 6 months for 3 years, and annually for 5 more years. The research team measures disease recurrence or death disease-free survival as the main outcome, along with overall survival, side effects, treatment tolerance, and quality of life. Safety monitoring and quality of life assessments are included to evaluate the impact of the treatments over the long term.

Researchers are evaluating the use of FDG-positron emission tomography PET-guided metastasis directed radiation therapy MDRT combined with standard treatments compared to standard treatments alone for men with metastatic hormone sensitive prostate cancer. This phase II trial focuses on patients whose prostate cancer has spread beyond the original site and remains sensitive to androgen deprivation therapy ADT. The study aims to see if this combined approach can improve progression-free survival and the complete response rate in different patient groups based on their treatment status. Participants are divided into two cohorts Cohort 1 includes patients undergoing cytotoxic chemotherapy plus ADT, while Cohort 2 includes those receiving ADT without cytotoxic chemotherapy. After six months of standard care, patients receive an FDG-PET scan to detect active cancer sites. Those with PET-avid disease are randomized to receive either MDRT plus standard care or standard care alone, with MDRT targeting up to 5 disease sites if no unacceptable toxicity occurs. Patients without PET-avid disease continue standard care. Throughout the trial, participants undergo CT scans, bone scans, and additional FDG-PET scans as applicable. Participants will be monitored regularly with imaging and lab tests, including prostate-specific antigen PSA levels, to measure cancer progression and response. Follow-up visits occur at 3 and 6 months after treatment completion, then every 6 months up to 36 months. Researchers evaluate progression-free survival, radiographic progression, PSA levels, skeletal events, response rates on imaging, and safety of MDRT. The study lasts up to three years, allowing detailed assessment of treatment effects and side effects over time.

Researchers are evaluating the addition of BMX-001 to usual symptom management compared to usual symptom management alone to reduce oral mucositis in patients receiving chemoradiation for head and neck cancer. Oral mucositis, which causes inflammation and mouth sores, is a common side effect of chemoradiation that can lead to pain and difficulty swallowing. This phase II trial aims to compare the incidence and duration of severe oral mucositis, as well as other side effects like xerostomia and radiation dermatitis, between the two treatment groups. Participants are randomly assigned to one of two groups. Both receive cisplatin chemotherapy once weekly or every three weeks and undergo image-guided intensity-modulated radiation therapy daily for seven weeks. In addition to usual symptom management, one group receives placebo injections subcutaneously twice a week for eight weeks, while the other group receives BMX-001 injections on the same schedule. Imaging such as CT and MRI scans and optional blood, serum, or plasma collection occur during the study. Throughout the trial, participants complete questionnaires and are monitored for side effects, toxicities, and oral mucositis severity up to 24 months after completing treatment. Follow-up visits occur at 1, 2, 3, 6, 12, and 24 months. Researchers assess patient-reported symptoms, duration of oral mucositis, radiation dermatitis, and overall survival outcomes. The trial also collects biological samples for future research.

Researchers are evaluating biomarker tests on tumor tissue to select personalized maintenance treatments for patients with extensive stage small cell lung cancer ES-SCLC. This phase II trial aims to determine how well these tests identify cancer subtypes and guide targeted therapies. The study also compares different maintenance treatments, including durvalumab, saruparib, ceralasertib, and monalizumab, which may affect tumor growth and immune response. Participants receive induction treatment with a platinum compound, etoposide, and durvalumab every 28 days for 4 to 6 cycles. After possible thoracic radiation, they are assigned to one of three cohorts based on cancer subtype and SLFN11 status. Each cohort is randomized to receive durvalumab alone or combined with another drug saruparib for cohort A, ceralasertib for cohort B, or monalizumab for cohort C. Maintenance cycles repeat every 28 days if disease does not progress or toxicity occurs. During the study, participants undergo imaging tests such as CT, PETCT, or MRI scans, and tissue and blood samples are collected for analysis. Researchers monitor progression-free survival and overall survival, as well as treatment safety and side effects, for up to three years. After completing study treatment, patients are followed for up to three years to assess long-term outcomes and collect specimens for future research.

Researchers are comparing two treatment approaches for patients with high anatomic stage estrogen receptor-positive, HER2-negative breast cancer who have a low risk of the cancer returning. The trial evaluates whether hormone therapy combined with the drug ribociclib works as well as chemotherapy followed by the same hormone therapy with ribociclib. Ribociclib targets enzymes needed for tumor cell growth, and hormone therapy lowers estrogen levels to help stop tumor growth. Chemotherapy works by killing or stopping the division and spread of cancer cells. Participants are first tested with the Oncotype DX assay to assess recurrence risk only those with scores between 0 and 25 continue. They are then randomly assigned to one of two groups one receives standard chemotherapy followed by hormone therapy plus ribociclib, and the other receives hormone therapy plus ribociclib without chemotherapy. Hormone therapy using letrozole, anastrozole, or exemestane is taken daily in 28-day cycles for at least five years, while ribociclib is taken daily for 21 days each cycle for up to three years. Patients undergo scans such as CT, bone scans, or PET-CT and may give blood samples during the study. Participants are followed closely with visits every 3 months during the first year, every 6 months for years 1 to 5, and annually for years 5 to 10. Researchers will assess invasive breast cancer-free survival up to 10 years and compare disease-free survival, recurrence rates, overall survival, and side effects between the two treatment groups. The study also aims to build a biorepository of tumor and blood samples for future research. This trial lasts until 2029, with ongoing monitoring to understand long-term outcomes and safety.

This trial investigates treatments for older adults newly diagnosed with acute myeloid leukemia AML who have a specific gene mutation called IDH2. It compares the combination of ASTX727 and venetoclax with or without the addition of enasidenib. The study aims to see if adding enasidenib helps more patients achieve remission by targeting the IDH2 mutation that contributes to leukemia growth. Participants are randomly assigned to one of two groups. One group receives ASTX727, an oral combination of cedazuridine and decitabine, plus venetoclax daily for 28 days in repeated 28-day cycles. The other group receives the same treatment with the addition of enasidenib every day in the cycle. Treatment continues unless the disease worsens or side effects become unacceptable. Throughout the trial, patients undergo blood and bone marrow tests to monitor their response. During the study, participants have regular blood sample collections, bone marrow aspirations, and biopsies to assess disease status and treatment effects. After completing treatment, follow-up visits occur monthly for the first year, then every two months in the second year, every three months in the third year, and every six months up to five years or until death. The main outcome measured is the rate of remission without detectable leukemia after two treatment cycles. Safety and long-term outcomes are also tracked.

Researchers are evaluating a combination targeted therapy called ViPOR for patients with relapsed or refractory aggressive B-cell lymphoma, specifically CD10-negative diffuse large B-cell lymphoma DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements. This phase II trial aims to measure how well ViPOR works in treating these lymphomas by assessing complete response rates and other clinical outcomes. The study also explores molecular and genetic factors that may influence treatment response or resistance using advanced gene-expression profiling and sequencing techniques. Participants receive a combination of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide Revlimid in 21-day cycles for up to six cycles, provided the disease does not progress or toxicity becomes unacceptable. Venetoclax, ibrutinib, prednisone, and lenalidomide are given orally on specific days of each cycle, while obinutuzumab is administered intravenously on the first two days. Throughout the study, patients undergo blood sample collection, PET scans, CT or MRI imaging, and may optionally have tumor biopsies and bone marrow aspiration and biopsy. During the study, participants are closely monitored with imaging and laboratory tests to evaluate treatment response and safety. After completing treatment, follow-up visits occur every six months for two years, then yearly for years three to five, and continued survival monitoring for up to ten years from registration. Researchers measure outcomes such as complete response rate, overall response, duration of response, progression-free survival, and overall survival, while also tracking adverse effects associated with the therapy.