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Found 9 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.
Actively Recruiting
Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.
Actively Recruiting
Researchers are evaluating the efficacy and safety of inavolisib combined with Phesgo compared to placebo with Phesgo as maintenance therapy in participants who have previously untreated HER2-positive advanced breast cancer with PIK3CA mutations. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on participants with locally advanced or metastatic breast cancer, aiming to understand the treatment impact after initial induction therapy. Participants will receive inavolisib orally once daily on Days 1 to 21 of each 21-day cycle, starting on Day 1 of Cycle 1 during maintenance treatment. Phesgo will be administered subcutaneously every three weeks on Day 1 of each cycle. The study includes an induction therapy phase where taxane-based chemotherapy is given after Phesgo. Optional endocrine therapy such as tamoxifen, aromatase inhibitors, or fulvestrant may be used based on the investigator's choice, with luteinizing hormone-releasing hormone agonists administered according to local guidelines. During the study, participants will be monitored for progression-free survival for up to approximately 40 months. Assessments include evaluation of heart function, organ function, and overall health status. Researchers will track the safety and effectiveness of the treatment combination through regular clinical evaluations and laboratory tests. The total duration includes maintenance treatment cycles and follow-up to measure outcomes and monitor safety.
Actively Recruiting
This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.
Actively Recruiting
Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.
Actively Recruiting
Researchers are evaluating and comparing standard neoadjuvant treatment options for older patients, aged 70 years and above, who have high-risk stage II or stage III rectal cancer. This multicenter, open-label, randomized pragmatic clinical trial aims to study the effectiveness and safety of conventional neoadjuvant therapy versus total neoadjuvant therapy in this patient group. Participants will be randomly assigned to one of two treatment groups. The conventional arm includes either short-course radiotherapy (5 daily fractions of 5 Gy) followed by surgery or watch & wait, with optional adjuvant chemotherapy, or long-course chemoradiotherapy (25-28 fractions of 1.8-2.0 Gy combined with chemotherapy) followed by surgery or watch & wait, and optional adjuvant chemotherapy. The total neoadjuvant therapy arm involves different regimens at the investigator's discretion, including RAPIDO, RAPIDO light, and OPRA regimens, combining radiotherapy, chemotherapy, and surgery or watch & wait. Each regimen varies by radiation dose, chemotherapy duration, and sequence. During the study, participants will undergo treatments as per their assigned group. Researchers will monitor overall survival, progression-free survival, peripheral sensory neuropathy, and grade 3 or higher toxicities at 3 years after randomization. The study involves assessments of clinical response and adherence to treatment protocols. Safety and efficacy will be tracked throughout the study period to evaluate long-term outcomes for these older patients with locally advanced rectal cancer.
Actively Recruiting
Researchers are observing the real-world use of the Maestro Platform to assist in laparoscopic surgery. The study focuses on how this device is used during surgery and monitors any related complications or issues. It aims to collect information on the safety and performance of the Maestro Platform during these surgical procedures. Patients scheduled for laparoscopic surgery will undergo the operation according to standard care practices, including typical port and instrument placements following local guidelines. The Maestro Platform may be used to hold and position the surgical scope and retractor as directed by the surgeon. Surgeons can switch back to manual minimally invasive surgery or convert to open surgery at any time if needed. Participants will be monitored for adverse events, including those related to the device or procedure, during and up to 30 days after surgery. The study tracks the completion of procedures using the Maestro Platform without needing to switch to other surgical methods due to device problems. Overall, the study records surgical outcomes and device safety over this period to better understand its use in actual clinical settings.
Actively Recruiting
This research investigates the use of Izalontamab Brengitecan (BMS-986507) compared to platinum-based chemotherapy (platinum-pemetrexed) for patients with non-small cell lung cancer (NSCLC) that has an EGFR mutation and has progressed after treatment with EGFR tyrosine kinase inhibitors (TKIs). The study is a randomized, open-label Phase 2/3 trial focusing on this specific patient group where prior EGFR TKI therapy has failed. Participants will receive either Izalontamab Brengitecan or a platinum-based chemotherapy regimen including cisplatin or carboplatin combined with pemetrexed. The drugs are given at specified doses on scheduled days. The study evaluates treatment effects over time, with follow-up lasting up to three years. During the study, researchers will monitor participants for progression-free survival using standardized criteria and determine the recommended Phase 3 dose of Izalontamab Brengitecan about three months after the first dose. Patients will undergo regular assessments to evaluate treatment response and safety over the study duration.
Actively Recruiting
Researchers are investigating whether olomorasib combined with pembrolizumab is more effective than pembrolizumab plus placebo for participants with resected KRAS G12C-mutant non-small cell lung cancer (NSCLC) in part A. In part B, they are assessing if olomorasib combined with durvalumab is more effective than durvalumab plus placebo for participants with unresectable KRAS G12C-mutant NSCLC. This Phase 3 study may last up to 3 years for each participant.