Westbrook

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating the effect of Gamunex-C on reducing serious infections in people with immune problems caused by Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma. This Phase 3 clinical trial focuses on patients with these conditions who have low IgG levels and aims to assess the safety, effectiveness, and behavior of Gamunex-C in the body over one year. All participants will receive Gamunex-C as an intravenous injection at a dose of 500 mg per kg of body weight once every 4 weeks. This treatment starts on Day 1 of the study and continues for a total of 13 doses through Week 48. The study is open-label and single-arm, meaning all enrolled participants receive the same treatment along with their standard medical care during this period. Throughout the study, participants will be monitored for serious bacterial infections occurring during the 1-year treatment phase and up to 28 days after their last dose or until they receive another immunoglobulin treatment. Researchers will track infection rates, safety concerns, and pharmacokinetics to understand how Gamunex-C performs. Participants will undergo regular evaluations, including laboratory tests and clinical assessments, to ensure their health and study compliance.

Researchers are evaluating treatments for people with extensive stage small-cell lung cancer (ES-SCLC). This phase 3 study compares the effectiveness of adding tarlatamab to a combination of durvalumab, carboplatin, and etoposide against the combination without tarlatamab. The main goal is to see which treatment better prolongs overall survival and progression-free survival over about 3.5 years. Participants receive intravenous infusions of the study drugs. One group gets tarlatamab combined with durvalumab, carboplatin, and etoposide, while the other group receives durvalumab, carboplatin, and etoposide alone. All treatments are given as first-line therapy for their lung cancer. During the study, participants will be monitored regularly to assess their response to treatment and overall health. Researchers will measure overall survival and progression-free survival to evaluate treatment benefit. The study also involves ongoing safety monitoring, and participants will be followed for up to approximately 3.5 years to collect these outcomes.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer (NSCLC) who have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are evaluating the drug exposure levels of tislelizumab given by subcutaneous injection compared to intravenous infusion as first-line treatment in adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This Phase 3 study includes approximately 351 patients and aims to understand how the drug behaves in the body depending on the administration method. The study consists of three main periods: screening, treatment, and follow-up. Participants will receive tislelizumab either as a subcutaneous injection or as an intravenous infusion combined with chemotherapy drugs including cisplatin, leucovorin, 5-fluorouracil, oxaliplatin, or capecitabine. The treatments are delivered according to the assigned group, with chemotherapy given by infusion or oral administration depending on the drug. The study monitors the drug concentrations at specific times after dosing to assess steady state and overall exposure. During the study, participants will undergo assessments to measure tumor response and provide tumor tissue for biomarker analysis. Performance status and organ function will be evaluated, along with safety monitoring throughout treatment and follow-up. The primary outcomes focus on measuring the predicted drug concentrations at 21 and 85 days after the first dose. The total participation includes time for screening, treatment, and post-treatment follow-up to ensure comprehensive monitoring.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating a new treatment for patients with triple-negative breast cancer that is locally recurrent, inoperable, or metastatic, who are not eligible for PD(L)1 immunotherapy based on their PD-L1 status. This Phase III trial compares the investigational drug pumitamig combined with chemotherapy to a placebo combined with chemotherapy. The study aims to measure how long participants live without their disease worsening and overall survival, with monitoring periods up to approximately 32 and 49 months respectively. Participants will be randomly assigned to one of two groups: one receiving pumitamig plus chemotherapy chosen by their physician, and the other receiving a matching placebo plus chemotherapy. Chemotherapy options include paclitaxel or nab-paclitaxel, gemcitabine plus carboplatin, or eribulin, all given as intravenous infusions. The treatment period continues until disease progression, unacceptable side effects, withdrawal, death, or trial end. The study includes a screening phase of up to 28 days, a treatment phase, a safety follow-up up to 90 days after the last dose, and a long-term survival follow-up. During the trial, participants will undergo assessments including tumor measurements based on RECIST criteria and tissue sample collection before starting treatment. The trial is double-blinded, so neither participants nor doctors know which treatment is given. Safety and efficacy are carefully monitored through regular evaluations. Participants remain in the study for as long as they continue treatment and follow-up, which may last several years depending on survival and consent.

Researchers are evaluating the use of sacituzumab tirumotecan combined with pembrolizumab compared to pembrolizumab alone in treating adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death ligand 1 (PD-L1) expression of 50% or higher. This phase 3 study aims to determine if the combination therapy can improve overall survival. Participants must have confirmed NSCLC without certain gene mutations and meet other health criteria, including good performance status. Participants are randomly assigned to receive either sacituzumab tirumotecan plus pembrolizumab or pembrolizumab alone, both given by intravenous infusion. Supportive care measures, such as anti-nausea or blood growth factor treatments, may be provided as needed. Those who complete the first course of pembrolizumab may be eligible for up to nine additional cycles of pembrolizumab if disease progression is confirmed by central review. During the study, participants will be monitored for overall survival up to about 49 months. Researchers will assess responses to treatment using standard criteria and monitor side effects and safety. Various evaluations, including tumor tissue analysis and health status assessments, will be conducted to understand the impact of the treatments. The study also tracks supportive care use and any adverse events throughout participation.