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Found 14 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years +All GendersPhase 3
555 locations
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Actively Recruiting

Researchers are evaluating Risvutatug Rezetecan Ris-Rez, a new medicine targeting specific proteins on cancer cells, in adults with relapsed extensive-stage small cell lung cancer ES-SCLC. This phase 3 study aims to compare how well Ris-Rez works versus the standard treatment, topotecan, by measuring cancer shrinkage, disappearance, and overall survival. The study also monitors safety, side effects, and tolerability of both treatments. Participants will be randomly assigned to receive either Ris-Rez or topotecan. Both treatments will be administered as part of the study to assess their effects. The study will follow participants for up to approximately 139 weeks to evaluate multiple outcomes including survival, tumor response, disease progression, and brain metastasis control. During the study, participants will have regular evaluations including scans, laboratory tests, vital signs, electrocardiograms, and performance status assessments. Researchers will track adverse events, laboratory changes, and participant experiences with the study drugs. The main outcome measured is overall survival up to about 113 weeks, with additional long-term monitoring of other health and disease measures throughout the study.

Age: 18Years +All GendersPhase 3
126 locations
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Actively Recruiting

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

Age: 18Years +All GendersPhase 3
229 locations
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Actively Recruiting

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

Age: 18Years +All GendersPhase 3
278 locations
A

Actively Recruiting

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.

Age: 18Years +All GendersPhase 3
402 locations
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Actively Recruiting

This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had common bile duct stones successfully removed using endoscopy. The study focuses on patients 75 years and older, including those with additional health issues, to determine if avoiding surgery is as safe as performing cholecystectomy. The main measurement is a combined outcome of death, serious complications, or recurring biliary problems within one year after randomization. Participants are randomly assigned to one of two groups one will have laparoscopic cholecystectomy within two weeks following stone removal, and the other will be managed without surgery but can have cholecystectomy later if needed. The study includes an interim safety check after the first 100 participants, with a plan to stop early if significant differences arise. Both groups are monitored over time to assess health outcomes and complications. During the study, participants will be followed for at least one year to track outcomes such as survival, complications, biliary events, quality of life, pain, and healthcare costs. Assessments occur at various intervals, including 30, 180, and 365 days after randomization. Researchers will evaluate these factors carefully to understand the benefits and risks of each approach, ensuring participant safety throughout the trial.

Age: 75Years +All GendersPhase Not Applicable
12 locations
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Actively Recruiting

Researchers are evaluating the effect of first-visit foam sclerotherapy in patients with venous leg ulcers. This study compares this treatment to the current standard scheduled treatment. The goal is to see how quickly the ulcers heal, with a follow-up period of one year. The study is a multicenter randomized controlled trial led by Oulu University Hospital and includes adult patients with venous leg ulcers verified by ultrasound. Participants are randomly assigned to one of two groups. In the first-visit foam sclerotherapy group, patients receive foam sclerotherapy during their first visit, including treatment under the ulcer, and scheduled endothermal ablation when suitable. In the scheduled treatment group, patients receive standard care with scheduled foam sclerotherapy andor endothermal ablation based on vein reflux anatomy. Both groups start compression therapy immediately with class 2 thigh-high compression or the best tolerated compression. Additional treatments for insufficient veins and truncal insufficiency are provided during scheduled visits. Throughout the study, researchers monitor the time it takes for ulcers to heal, tracking this over 365 days. They also assess quality of life using EQ-5D and Wound-QOL questionnaires and measure ulcer area. Follow-up visits include evaluations of venous health and treatment effects. The total planned enrollment is 248 patients, and the study continues until March 2026. Safety and adherence to treatment are monitored during the one-year follow-up.

Age: 18Years +All GendersPhase Not Applicable
5 locations
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Actively Recruiting

This research aims to evaluate the effectiveness of different methods to help people stop smoking combined with low-dose CT LDCT screening for lung cancer. It focuses on individuals aged 50 to 74 who have a significant smoking history and are current smokers. The study compares smoking cessation methods, the impact of LDCT screening on lung cancer detection, the stage at which lung cancer is found, and survival specific to lung cancer. Participants are randomly assigned to one of three groups smoking cessation using a smartphone application plus LDCT screening, smoking cessation using written materials plus LDCT screening, or smoking cessation with the smartphone application alone without LDCT screening. The interventions involve digital support for quitting smoking and lung cancer screening using low-dose CT scans. The study tracks outcomes over time, including smoking cessation rates and lung cancer findings. During the study, researchers will monitor smoking cessation success at three, 12, and 24 months, verify smoking status with carbon monoxide measurements, and assess lung cancer incidence and screening results at various time points including up to ten years. Participants will be asked to use the assigned smoking cessation method and, if applicable, undergo LDCT scans. The study lasts several years to capture both short- and long-term outcomes related to smoking behavior and lung cancer detection.

Age: 50Years - 74YearsAll GendersPhase Not Applicable
5 locations
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Actively Recruiting

Researchers are evaluating a study medicine called MK-1084 for treating advanced or metastatic nonsquamous Non-Small Cell Lung Cancer NSCLC with a specific KRAS G12C gene mutation. This phase 2 randomized trial aims to assess the safety of MK-1084 and how well it might shrink or eliminate tumors in people with this type of lung cancer. The study is sponsored by Merck Sharp & Dohme LLC and focuses on targeted therapy for this genetic mutation in cancer cells. Participants are randomly assigned to one of three treatment groups one group receives Pembrolizumab plus MK-1084 another group receives Pembrolizumab, MK-1084, and Cetuximab and the third group receives Pembrolizumab, MK-1084, and sacituzumab tirumotecan sac-TMT. Pembrolizumab is given every 6 weeks intravenously, Cetuximab and sac-TMT are administered every 2 weeks intravenously, and MK-1084 is given orally according to a dosing regimen. Rescue medications are provided to prevent infusion reactions and oral side effects. During the study, participants are monitored for dose limiting toxicities, adverse events, and discontinuations due to side effects over up to 84 months. Tumor response is measured using RECIST 1.1 criteria reviewed independently. Blood samples will be taken at designated times to study MK-1084 concentrations. Researchers will also track duration of response, progression-free survival, and overall survival. The study involves regular visits for treatment administration and safety assessments throughout the trial period.

Age: 18Years +All GendersPhase 2
38 locations
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Actively Recruiting

Researchers are evaluating the outcomes of a nonoperative management approach for rectal cancer in patients who have a complete clinical response after neoadjuvant therapy. This prospective, non-randomized, single-arm international trial aims to establish a unified protocol and compare the oncological results and organ preservation rates with practices worldwide. The study focuses on disease-free survival two years after starting nonoperative management as the primary endpoint. Patients with confirmed complete clinical response after standard neoadjuvant treatment undergo nonoperative surveillance involving clinical examinations, laboratory tests, and imaging such as digital rectal exams, endoscopy, rectal MRI, and body CT scans. This single treatment arm follows a watch-and-wait approach to monitor for local regrowth or distant spread, avoiding surgery unless cancer recurs. Follow-up visits occur every three months for the first two years and every six months for the next three years. Participants will be closely monitored through clinical assessments and imaging to detect any recurrence or metastases. Researchers will measure survival outcomes, organ preservation rates, quality of life, and treatment-related complications up to five years. Data are collected securely and pseudonymously, with costs of follow-up covered by the healthcare system. The study may end at a center if local recurrence exceeds 30% after complete clinical response.

Age: 18Years +All GendersPhase Not Applicable
13 locations

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