Longnan

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 conducting a multicenter observational study to better understand the treatment outcomes for patients diagnosed with psoriasis by dermatologists in clinic settings across China. Psoriasis is a chronic, recurrent inflammatory disease influenced by genetic and environmental factors, presenting as erythematosquamous lesions and potentially affecting multiple organs. The study aims to compare the effectiveness of various treatments chosen by patients, including phototherapy, traditional systemic therapies, and biologics, in real-world clinical practice. This non-interventional study allows patients to select their preferred treatment without restrictions. Data is collected primarily through a phone application called "Psoriasis New World," enabling continuous monitoring of patient progress. The study evaluates multiple outcomes such as the Psoriasis Area and Severity Index (PASI), which measures skin lesion severity and body area involvement, along with the Physician Global Assessment, Investigator Global Assessment, Body Surface Area affected, and Dermatology Life Quality Index. Patient safety is monitored throughout, including the recording of any adverse events and laboratory tests such as liver function. Participants will be followed over six months to measure the percentage achieving complete clearance of psoriasis symptoms (PASI 100). Regular assessments of disease severity and quality of life changes will be conducted remotely via the app. Continuous safety monitoring ensures any side effects or complications are documented. This approach provides comprehensive real-world evidence on how different psoriasis treatments perform in routine clinical care.

Researchers are evaluating depemokimab as a potential add-on treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who also have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab in improving health outcomes for people whose COPD is not well controlled despite standard inhaler therapy. Participants must have a history of elevated blood eosinophil levels and confirmed lung function measurements consistent with COPD. Participants will be randomly assigned to receive either depemokimab, given as a sterile liquid, or a placebo solution containing sodium chloride. Both treatments will be administered as part of a double-blind, placebo-controlled trial across multiple centers. The study includes patients who have been on optimized inhaler treatments including inhaled corticosteroids combined with long-acting bronchodilators for at least six months before the study begins. During the study, participants will be monitored over a period extending up to 104 weeks to measure the annualized rate of moderate to severe COPD exacerbations. Researchers will conduct regular assessments including lung function tests, symptom questionnaires, and safety evaluations. The study will also track participants' adherence to treatment and record any side effects or health changes to better understand the long-term impact of depemokimab.

Researchers are conducting a phase II clinical trial to evaluate the safety, tolerability, and preliminary effectiveness of JS207 in patients with advanced non-small cell lung cancer (NSCLC) who have experienced disease progression after platinum-based chemotherapy and immunotherapy. This study focuses on patients with locally advanced or metastatic NSCLC that cannot be treated with surgery or radical radiochemotherapy. The goal is to understand how JS207 performs in this group who have limited treatment options. Participants receive one of several treatment combinations: JS207 injection alone at 10mg/kg or other dosages; JS207 combined with docetaxel at 75mg/m2 every three weeks; or JS207 combined with JS004 injection at 200mg every three weeks. These treatments are given in cycles spaced three weeks apart, and the study monitors their effects over time. During the trial, researchers will assess the objective response rate over 1.5 years to measure treatment effectiveness. Participants will undergo regular evaluations to monitor safety and tolerability. The study includes adults aged 18 to 75 years, and various assessments will be conducted to track disease status and adverse effects throughout the treatment period.

Langerhans cell histiocytosis (LCH) is a rare disorder mainly affecting children, caused by excessive growth and buildup of Langerhans cells in various tissues. While mild forms may resolve or cause few issues, multisystem LCH affects multiple organs and carries a higher risk of serious complications and poorer outcomes. Standard treatments combine prednisone and chemotherapy, but many children experience relapse or resistance, which can lead to lasting health problems. Over half of LCH cases have a mutation that activates the MAPK pathway, prompting interest in targeted drugs that block this pathway. This trial compares a modified standard chemotherapy regimen called LCH-III alone versus the same chemotherapy combined with luvometinib, a selective MEK1/2 inhibitor targeting the MAPK pathway. Participants receive prednisone orally, vincristine intravenously, and mercaptopurine orally as part of chemotherapy. Luvometinib is given daily by mouth alongside these drugs in the experimental group. The study enrolls children with multisystem LCH and aims to see if adding luvometinib improves treatment outcomes. Children in the study will be closely monitored through clinical evaluations, imaging, and laboratory tests. Researchers will track event-free survival for up to two years, noting any disease progression or relapse. Consent and follow-up assessments are required throughout. This multicenter, randomized trial seeks to determine if combining targeted therapy with chemotherapy offers better disease control and fewer relapses for pediatric multisystem LCH patients.

Researchers are evaluating MCLA-129, a human bispecific antibody targeting EGFR and cMet, in patients with advanced solid tumors including non-small cell lung cancer (NSCLC), head and neck cancer, and colorectal cancer. This open-label, multicenter Phase I/II study aims to assess the safety, pharmacokinetics, and anti-tumor activity of MCLA-129. The study includes two parts: Part I focuses on dose finding and safety in patients with EGFR or MET positive tumors, and Part II further evaluates efficacy and safety in specific patient cohorts with advanced NSCLC and other solid tumors based on biomarker profiles. MCLA-129 is given as an intravenous infusion on a 28-day cycle. Part I includes a dose escalation and expansion phase to determine the maximum tolerated dose and observe dose-limiting toxicities during the first 28 days. Part II expands into parallel cohorts defined by specific genetic markers and tumor types, such as patients with EGFR mutations resistant to prior therapies, MET amplification, or exon 14 skipping mutations, as well as those with advanced colorectal cancer or other solid tumors that have failed standard treatments. Participants will undergo regular assessments including tumor measurements every 6 weeks to monitor response and disease progression for up to approximately two years. Safety is closely monitored during treatment and for 30 days after the last dose. Other evaluations include pharmacokinetic sampling and adverse event tracking. The study requires participants to meet certain health status, organ function, and biomarker criteria and involves follow-up procedures to assess long-term outcomes and treatment effects.

Researchers are investigating the effects of sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132) compared to standard treatments in people with previously treated extensive stage small cell lung cancer (ES-SCLC). The main goal is to compare how SG versus standard care impacts overall survival up to 4.5 years after treatment. This phase 3, global, multicenter, randomized, open-label study focuses on participants who have already received prior platinum-containing chemotherapy. Participants are randomly assigned to receive either sacituzumab govitecan or one of the standard care drugs, including topotecan, amrubicin (in Japan only), or lurbinectedin (where approved). All drugs are given by intravenous infusion. The study includes a treatment period where these medications are administered according to the protocol, with doses and schedules managed by the study teams. During the study, participants will be monitored regularly for overall survival and other health outcomes. Assessments will include imaging scans like CT or MRI to measure disease status, along with clinical evaluations and symptom monitoring. The study tracks safety and treatment effects over time, aiming for a follow-up of up to 4.5 years. Participants will have their condition reviewed throughout to evaluate how the treatments impact their survival and disease progression.

This research focuses on improving lung cancer diagnosis and treatment by creating synthetic PET images from CT scans. The study aims to develop a model that links anatomical CT data with metabolic PET data, enhancing the biological relevance and clinical usefulness for patients with non-small cell lung cancer. This approach is intended to support more precise diagnosis and prognosis by validating the model's clinical value in a real-world setting. Participants will undergo PET-CT scans before starting systemic treatment for their tumors. The study collects paired diagnostic CT and FDG-PET scans to establish the anatomical-to-metabolic mapping. This observational study is conducted across multiple centers, monitoring the consistency and quality of the synthetic PET data compared to actual PET scans. During the study, researchers will assess image quality measures such as Structural Similarity Index (SSIM), Peak Signal-to-Noise Ratio (PSNR), and metabolic parameter consistency over a one-year period from December 2025 to December 2026. Participants will provide informed consent, and their diagnostic scans and pathological examination results will be used to evaluate the accuracy and clinical utility of the synthetic PET images.

Researchers are evaluating the effectiveness and safety of third-generation tyrosine kinase inhibitors (TKIs) combined with azacitidine and a B-cell lymphoma-2 (Bcl-2) inhibitor in patients with myeloid blast phase chronic myeloid leukemia (CML-MBP). This condition has a poor prognosis, and currently, there is no standard induction treatment. Previous studies have shown promising results using TKIs with hypomethylating agents, but data on third-generation TKIs in this setting is limited. This study also includes multi-omics analyses to identify potential biomarkers related to treatment outcomes. The study treatments include ponatinib taken orally daily, azacitidine administered subcutaneously on days 1 to 7, venetoclax taken orally daily on days 1 to 14, and olverembatinib taken orally every other day on days 1 to 28 in a 28-day cycle. Participants will receive these treatments in repeated 28-day cycles unless there is disease progression, unacceptable side effects, or a need for hematopoietic stem cell transplant (HSCT). Participants will be monitored throughout the study with assessments at the end of each 28-day cycle, focusing on measuring major hematologic response. The study evaluates safety and efficacy during these cycles and includes laboratory tests such as liver and kidney function, heart function via ejection fraction and electrocardiogram, and other standard clinical assessments. The total duration of participation depends on treatment response and tolerance.

Researchers are evaluating the effects of weekly subcutaneous injections of semaglutide for 12 weeks in adults with type 2 diabetes mellitus (T2DM). This study compares semaglutide treatment to a program of energy (caloric) restriction to see how each approach affects blood sugar control, weight loss, inflammation, liver fat, and other health factors. The trial also examines changes in subcutaneous and visceral fat, aiming to understand the molecular mechanisms behind these interventions and provide strong evidence to guide treatment timing and targets for people with T2DM. Participants are assigned to one of two groups: one receives semaglutide injections starting at 0.25 mg weekly for 2 weeks, increasing to 0.5 mg for the next 2 weeks, and finally 1.0 mg weekly from weeks 5 to 12. The other group follows a daily caloric restriction plan based on gender, with males consuming 1,500 to 1,800 kcal and females 1,200 to 1,500 kcal. Both treatments last for 12 weeks. Throughout the study, participants will have blood tests to measure HbA1c, fasting plasma glucose, and 2-hour postprandial glucose from the start until the end of treatment. Researchers will also monitor weight, inflammatory markers, and liver fat changes. Participants are expected to adhere to their assigned treatment plans and attend follow-up visits. The total treatment duration is 12 weeks, with assessments focused on the impact of these interventions on diabetes and related metabolic factors.