Baden

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.

Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared to placebo plus CDK4/6i and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. It aims to assess treatment outcomes in the first-line setting for this specific breast cancer type. Participants will be assigned to receive either oral inavolisib once daily or a matching oral placebo once daily. All participants will also receive a CDK4/6 inhibitor on either Days 1-21 or Days 1-28 of each 28-day cycle, along with daily oral letrozole. This randomized, double-blind study will compare these two treatment combinations to monitor differences in disease progression and safety. Throughout the study, researchers will evaluate progression-free survival from the time of randomization until disease progression or death, up to 7 years. Participants will undergo assessments including tumor measurements by RECIST criteria, performance status evaluations, and monitoring of blood and organ function before treatment begins. Safety and efficacy will be closely observed during treatment, aiming to provide detailed long-term data on the study therapies.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the benefit of adding adjuvant durvalumab after neoadjuvant chemotherapy combined with durvalumab and surgery in patients with early-stage, operable non-small cell lung cancer (NSCLC), specifically stages IIB to IIIB (N2). This international, multicenter, open-label phase III trial aims to see if additional durvalumab treatment after surgery improves disease-free survival in patients who do not achieve complete pathological response after initial therapy. The study includes patients with resectable tumors who meet specific staging and health criteria.

Researchers are evaluating whether adding zilovertamab vedotin to standard treatment helps people with previously untreated diffuse large B-cell lymphoma (DLBCL) live longer without their cancer growing or spreading. This Phase 3 study compares zilovertamab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). The goal is to see if the new combination improves progression-free survival. Participants receive treatments through intravenous infusions of study drugs including zilovertamab vedotin, rituximab or its biosimilar, cyclophosphamide, doxorubicin, and vincristine, along with oral prednisone or prednisolone as per approved guidelines. Some may receive rescue medication such as granulocyte colony-stimulating factor (G-CSF) if needed. The study is open-label and conducted across multiple centers. During the study, participants are closely monitored for how long they live without their disease worsening, with follow-up up to approximately 50 months. Assessments include imaging scans like PET to evaluate disease status, heart function tests, and regular evaluations of overall health and side effects. Safety is monitored throughout, and researchers measure progression-free survival as the primary outcome to determine the effectiveness of the treatments.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are evaluating tarlatamab, an intravenous drug, in patients with extensive-stage small cell lung cancer (ES-SCLC) who have an ECOG performance status of 2 and have already received one line of platinum-etoposide chemotherapy with immune checkpoint inhibition. This international, multicenter, single-arm phase II trial aims to assess the effectiveness of tarlatamab by measuring the overall survival rate at 12 months after enrollment, with follow-up for up to approximately 41 months. Participants receive tarlatamab as an intravenous infusion starting with 1 mg on day 1, followed by 10 mg on days 8 and 15 of the first cycle. After that, 10 mg infusions are given every two weeks until the disease progresses, unacceptable side effects occur, or the patient decides to stop treatment. The treatment follows disease progression criteria defined by RECIST v1.1 and continues under close monitoring. Throughout the study, patients are monitored for survival and treatment safety. Researchers assess overall survival from enrollment until death from any cause. The study involves regular clinical evaluations to track disease progression, side effects, and patient well-being. Participation duration varies depending on treatment response and disease status, with safety and effectiveness observed for up to 41 months after enrollment.

Researchers are evaluating an experimental drug called odronextamab for adults with previously untreated follicular lymphoma, a type of non-Hodgkin lymphoma. This Phase 3 study aims to assess the safety, tolerability, and effectiveness of odronextamab alone and compared to the current standard treatments, including rituximab combined with different types of chemotherapy. The study also examines side effects, drug levels in the blood, antibody responses against odronextamab, and the impact on quality of life and daily activities. The study consists of two parts: Part 1 is non-randomized and focuses on the safety and tolerability of odronextamab given alone. Part 2 is randomized and controlled, comparing odronextamab to rituximab combined with chemotherapy regimens such as CHOP, CVP, or Bendamustine-containing therapies. All treatments are administered according to the study protocol. Participants receive these treatments to evaluate how well odronextamab works versus standard care. Participants will undergo various assessments including imaging scans like CT or MRI to measure disease, blood tests to monitor bone marrow and liver function, and evaluations of side effects up to two years. Researchers will track dose-limiting toxicities within 35 days and assess complete response rates over 30 months. Safety and side effects will be monitored continuously, and quality of life will also be evaluated. The total length of participation depends on treatment and follow-up schedules defined in the protocol.

Researchers are evaluating a new medicine called Sofetabart Mipitecan (LY4170156) in adults with certain types of ovarian, peritoneal, and fallopian tube cancers. This phase 3 study has two parts: Part A focuses on participants whose cancer no longer responds to platinum-based chemotherapy, while Part B includes those whose cancer still responds to platinum-based treatments. The study aims to compare Sofetabart Mipitecan against current standard treatments and to better understand its safety. Participants receive treatments administered through intravenous (IV) infusions. In Part A, Sofetabart Mipitecan is compared with various chemotherapy drugs or mirvetuximab soravtansine. In Part B, Sofetabart Mipitecan combined with bevacizumab is compared with platinum-based chemotherapy plus bevacizumab. Each participant's time in the study depends on how they respond to the treatment. During the study, researchers monitor participants for progression-free survival, measuring the time from randomization until cancer progression or death, for up to 70 months. Participants undergo assessments including scans to track tumor changes and evaluations of safety and side effects. The study collects tumor tissue samples and monitors participants' health status regularly to understand treatment effects and safety over time.