West End

Researchers are evaluating MK-1045, an immunotherapy, in people with two types of non-Hodgkin lymphoma NHL follicular lymphoma FL, which grows slowly, and diffuse large B-cell lymphoma DLBCL, which grows more quickly. NHL is a cancer of the lymphatic system causing swollen lymph nodes. This study aims to assess the safety and tolerability of MK-1045 and to see if it can shrink or eliminate these lymphomas. Participants are randomly assigned to one of four groups receiving different doses or methods of MK-1045 administration. Dosages A, B, and D are given by intravenous IV infusion, while Dosage C is given by subcutaneous SC injection. Treatment lasts for up to approximately one year or until participants stop treatment for any reason. During the study, participants will be monitored for adverse events and treatment side effects, with measurements including tumor response using specific criteria. Blood levels of MK-1045 will also be tracked. The study involves regular visits for infusions and assessments. Participant safety and treatment effects will be followed for up to about 49 months in total.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating the effectiveness and safety of Ifinatamab Deruxtecan I-DXd compared to the treatment chosen by a physician for people with relapsed small cell lung cancer SCLC. This Phase 3 study aims to see if I-DXd can help participants live longer than current treatments, while also examining other effects such as patient-reported outcomes, immune response, and the drugs behavior in the body. Participants will be randomly assigned to one of two groups. One group will receive I-DXd as an intravenous infusion at a dose of 12 mgkg every 21 days until the disease worsens, unacceptable side effects occur, or other stopping reasons arise. The other group will receive one of the standard treatments chosen by their doctortopotecan, lurbinectedin, or amrubicinaccording to local approved dosing guidelines and until treatment discontinuation criteria are met. During the study, participants will be closely monitored with regular imaging and assessments to track tumor response, disease progression, and quality of life using questionnaires. Safety events and immune responses will also be recorded. Pharmacokinetic samples will be collected at specified times to understand how I-DXd behaves in the body. Participants may remain in the study for up to approximately 3.7 years, allowing for long-term evaluation of outcomes and safety.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

Researchers are evaluating the safety and effectiveness of zilovertamab vedotin ZV combined with standard treatments for people with relapsed or refractory diffuse large B-cell lymphoma rrDLBCL. This Phase 23 study is divided into two parts Dose Confirmation and Efficacy Expansion. It aims to compare ZV combined with rituximab, gemcitabine, and oxaliplatin R-GemOx against R-GemOx alone, and ZV combined with bendamustine rituximab BR against BR alone, focusing on progression-free survival. Enrollment in the BR-related arms has been discontinued with no analysis planned for those arms.

Researchers are evaluating the effectiveness and safety of standard chemotherapy with or without the drug INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma PDAC with a KRAS G12D mutation and have not received prior treatment for metastatic disease. This phase 3 study compares two groups to understand whether adding INCB161734 to chemotherapy improves outcomes in this condition. Participants will receive either oral INCB161734 tablets combined with chemotherapy chosen by their doctor either mFOLFIRINOX or GemNabP or a placebo tablet combined with the same chemotherapy options. The treatments are given according to the study protocol, and the study is conducted in a randomized, double-blind design to fairly compare the effects of INCB161734 plus chemotherapy versus placebo plus chemotherapy. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response up to about two to three years. Researchers will also assess treatment side effects, quality of life using questionnaires, and other health outcomes. Participants will have regular visits for assessments, and safety will be closely tracked throughout the study period, which lasts until the study completion date in 2029.

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 for the first treatment of metastatic microsatellite stable colorectal cancer. This is a Phase 3 randomized trial focusing on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery. Participants receive either INCA33890 or a placebo, both given alongside bevacizumab and FOLFOX chemotherapy at doses defined by the study protocol. Treatment is administered as part of the first-line therapy for metastatic disease, with participants randomly assigned to one of the two groups. During the study, participants will be regularly monitored through imaging and clinical assessments to measure progression-free survival for up to three years. Additional outcomes include overall survival, response to treatment, side effects, and quality of life measures up to four years. Safety and treatment effects will be closely followed throughout the trial period.

Chronic lymphocytic leukemia CLL is the most common type of leukemia affecting blood cells. Researchers are evaluating the safety of combining oral venetoclax with either intravenously infused obinutuzumab or oral acalabrutinib for treating previously untreated CLL. The study focuses on assessing adverse events and changes in disease activity in adult participants. Participants are randomly assigned to one of four treatment groups. Arm A receives oral venetoclax with IV obinutuzumab, including a 5-week venetoclax ramp-up period. Arms B, C, and D receive oral venetoclax combined with oral acalabrutinib, with different venetoclax ramp-up schedules varying between 5 weeks and modified ramp-up periods. The total study duration is approximately 28 months. Participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect checks, and questionnaires to monitor treatment effects. Researchers will measure the percentage of participants experiencing laboratory tumor lysis syndrome and hyperkalemia during treatment. Safety monitoring and evaluations of tumor burden changes will continue for up to 28 months throughout the study.

Researchers are evaluating the safety, tolerability, and activity of SAR448501DR-0201, a bispecific antibody, in adults with relapsed or refractory B-cell non-Hodgkin lymphoma who have not responded to at least two prior standard therapies. This open-label phase 1 study aims to find the optimal biological dose by assessing pharmacokinetics, pharmacodynamics, clinical effects, and immune response in a group of patients with this condition. Participants will receive SAR448501 for up to 52 weeks in different dose levels, with multiple ascending doses studied across several cohorts. The study includes an initial screening period lasting up to 28 days, followed by the treatment period, then a safety follow-up of about 28 days. Afterward, participants enter a long-term follow-up phase every three months that continues until withdrawal of consent, death, or study closure. During the study, patients will undergo evaluations to monitor adverse events, disease response, and drug levels in the body. Assessments include measuring tumor response, survival outcomes, and immune reactions. Researchers will also collect biopsy samples before and during treatment when safely possible. Overall, each participants involvement lasts about three years, including screening, treatment, safety monitoring, and long-term follow-up visits.