West End

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

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.

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) compared to treatment chosen by physicians for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). The study aims to find out if I-DXd can improve the objective response rate, meaning the proportion of patients whose cancer shrinks or disappears, and extend overall survival time compared to other treatments. Secondary goals include assessing safety, patient-reported outcomes, immune response to I-DXd, B7-H3 protein levels, and how the drug is processed in the body. Participants will receive either I-DXd at a dose of 12 mg/kg given intravenously on the first day of each 21-day treatment cycle or one of the physician's choice treatments including Topotecan, Amrubicin, or Lurbinectedin, administered according to local standards of care. The study is randomized and open-label, meaning treatments are assigned by chance and both patients and doctors know which treatment is given. During the study, participants will be closely monitored with tumor assessments to evaluate response and detect disease progression, safety evaluations, and quality of life questionnaires. The main outcomes measured are the objective response rate assessed by a blinded independent review and overall survival time, tracked for up to approximately five years after randomization. Researchers will also monitor for any adverse effects and collect health economics data to understand the broader impact of treatments.

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 the effectiveness and safety of standard chemotherapy combined with bevacizumab, with or without the addition of INCA33890, as the first treatment option for patients with metastatic microsatellite stable colorectal cancer. This phase 3 randomized, double-blind study focuses on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery and who have not received prior systemic treatment for their metastatic disease. Participants will receive standard-of-care chemotherapy (FOLFOX) and bevacizumab both administered at protocol-defined doses. They will be randomly assigned to also receive either INCA33890 or a placebo, with dosing also defined by the study protocol. The treatments will be given as the initial therapy for metastatic disease, aiming to compare the outcomes between the groups receiving INCA33890 and those who do not. Throughout the study, participants will be monitored for progression-free survival for up to three years. Researchers will assess disease progression using measurable disease criteria and regularly evaluate participants' health status and organ function through laboratory tests. Safety and treatment response will be closely followed, with the goal of determining how well the treatments control the cancer without unacceptable side effects.

Chronic lymphocytic leukemia (CLL) is the most common type of leukemia affecting blood cells. This research aims to evaluate the safety of the drug venetoclax when combined with either obinutuzumab or acalabrutinib for treating adults with previously untreated CLL. The study focuses on monitoring side effects and changes in disease activity to better understand treatment risks, including the risk of tumor lysis syndrome (TLS). Participants will be assigned to one of four treatment groups. All will receive oral venetoclax with different ramp-up schedules combined with either intravenous obinutuzumab or oral acalabrutinib. Treatment arms vary in their dosing schedules and combination therapies. The total study period lasts about 28 months, during which participants receive their assigned treatments and monitoring. Throughout the study, participants will have regular visits at hospitals or clinics for medical exams, blood tests, and side effect checks. Questionnaires will also be completed to assess their condition. Researchers will track the occurrence of TLS and other laboratory indicators related to safety. This ongoing monitoring will help understand treatment effects and ensure participant safety over the study duration.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, clinical activity, and immunogenicity of SAR448501/DR-0201 in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). This open-label, phase 1 study aims to identify optimal biological doses of the investigational drug in this patient group who have failed at least two prior standard therapies and have no recognized treatment options providing clinical benefit. The study will last about three years for each participant, including various study phases. Participants receive multiple ascending doses of SAR448501/DR-0201 during a 52-week treatment period. The study includes a screening period of up to 28 days before treatment, followed by a safety follow-up period of approximately 28 days after the last dose. After these periods, participants enter a long-term follow-up phase with assessments every three months until withdrawal of consent, death, or study closure. Throughout the study, participants undergo regular monitoring for treatment-emergent adverse events and assessments to determine the best dosing regimen during the first treatment cycle. Evaluations include safety checks, clinical activity observation, and pharmacological studies. The long-term follow-up provides ongoing monitoring for safety and efficacy until the study's end or participant withdrawal.

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.

Researchers are evaluating treatment options for patients with early-stage classical Hodgkin lymphoma who have not received prior therapy. This international phase III trial runs two parallel studies in different regions, combining data to better understand treatment effects. The trial compares two chemotherapy regimens, ABVD and A2VD, with treatment adapted based on PET-CT scan results after two cycles to guide further therapy. Participants will be randomly assigned to receive either ABVD chemotherapy (doxorubicin, bleomycin, vinblastine, and dacarbazine) or A2VD chemotherapy (doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support). PET-CT scans are performed after one cycle for exploratory purposes and after two cycles to determine subsequent treatment. Depending on PET results, patients may receive additional chemotherapy cycles or involved site radiotherapy following ILROG guidelines. Those with poor response discontinue trial treatment and receive alternative therapy. During the study, patients undergo PET-CT scans and regular assessments to monitor treatment response and safety. Follow-up continues for at least five years after treatment completion to assess progression-free survival. Researchers collect clinical data and imaging results to evaluate outcomes, with central review of PET scans guiding treatment adaptations. Participants are monitored for side effects and overall health throughout the trial period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of tuspetinib (HM43239) in patients diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) who have relapsed or are refractory after at least one prior therapy, as well as in newly diagnosed AML patients. This Phase 1/2, open-label, multi-center study aims to determine a safe and potentially effective dose of tuspetinib for future research. Tuspetinib is given as a daily continuous oral dose either alone or combined with venetoclax or venetoclax plus azacitidine, depending on the study part. Part C evaluates tuspetinib alone in relapsed or refractory AML patients, focusing on safety and preliminary efficacy. Part D assesses tuspetinib combined with venetoclax and azacitidine in newly diagnosed AML patients ineligible for intensive chemotherapy. Participants will undergo assessments including monitoring of drug-related adverse events over 4 years, pharmacokinetic measurements like plasma concentration and half-life during the first treatment cycle, and determination of the recommended Phase 2 dose. Safety, tolerability, and efficacy are carefully evaluated throughout treatment, and participants agree to avoid other interventional studies during the trial.