Longnan

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.

Psoriasis is a chronic, recurring inflammatory disease influenced by genetics and environmental factors, marked by skin lesions that can affect multiple organs. Researchers are evaluating the effectiveness of different treatments chosen by patients in real-world clinical settings, comparing phototherapy, traditional systemic therapies, and biologics among Chinese psoriasis patients. This observational study aims to gather real-world evidence under routine care without intervention. Patients diagnosed with psoriasis by dermatologists choose their preferred treatments, which may include phototherapy, traditional systemic drugs, or biologics. The study does not assign treatments but observes outcomes as patients follow their chosen therapies. Data collection is supported through a phone application called Psoriasis New World, and the study includes multiple centers. Participants will be assessed regularly for treatment effectiveness using measures such as the Psoriasis Area and Severity Index PASI, Physician and Investigator Global Assessments, Body Surface Area affected, and Dermatology Life Quality Index. Adverse events and laboratory tests, including liver function, will be monitored throughout up to 12 months. The primary outcome is the percentage of patients achieving complete skin clearance PASI 100 at 6 months, with additional follow-up evaluations at 12 months.

Researchers are evaluating depemokimab as an additional treatment for adults with moderate to severe chronic obstructive pulmonary disease COPD who have uncontrolled symptoms and type 2 inflammation. This Phase 3 study aims to assess the safety and effectiveness of depemokimab in reducing COPD flare-ups compared to a placebo, with the goal of improving patient outcomes. Participants will be randomly assigned to receive either depemokimab or a placebo alongside their standard COPD care. Depemokimab is given as a sterile liquid formulation, while the placebo is a sterile sodium chloride solution. The study is double-blind, meaning neither participants nor researchers know which treatment is given. Treatment and observation will continue for up to 104 weeks, allowing thorough assessment over two years. During the study, participants will undergo regular evaluations including lung function tests, symptom questionnaires like the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring of exacerbations requiring medical attention. Researchers will track the annual rate of moderate to severe COPD exacerbations as the primary outcome. Safety will be closely monitored throughout the trial, and participants health status will be reviewed periodically until study completion, which may last until August 2029.

Myopia is a common and irreversible vision disorder that affects quality of life. The standard method to measure refractive error in adults considering optical or surgical correction is cycloplegic refraction, but it can be time-consuming, uncomfortable, and slow to recover from. This research aims to develop machine learning models that predict cycloplegic refractive error in adults with myopia using standard non-cycloplegic eye measurements, potentially reducing the need for cycloplegic drops while identifying patients who still require them. The study uses data from adults with myopia undergoing routine eye exams at refractive surgery centers. Participants are divided into two groups based on the difference between non-cycloplegic and cycloplegic refraction values those with a difference of 0.50 diopters or more and those with less than 0.50 diopters. All participants receive routine cycloplegic refraction with tropicamide, and a machine learning model is applied to non-cycloplegic parameters to predict the cycloplegic spherical equivalent. Participants undergo paired non-cycloplegic and cycloplegic eye measurements within 7 days. Researchers evaluate the accuracy of the predicted cycloplegic refraction, how well the model identifies patients needing cycloplegic refraction, and the agreement between predicted and measured values. The study collects detailed clinical data including visual acuity, corneal health, and intraocular pressure. Participants are observed without additional interventions beyond standard eye exams and refraction tests.

Researchers are evaluating the safety, tolerability, and early effects of JS207 in adults with advanced non-small cell lung cancer NSCLC who have experienced disease progression after receiving platinum-based chemotherapy and immunotherapy. This phase II trial aims to assess how well JS207 works alone or combined with other treatments in this setting. Participants receive one of three treatments JS207 with docetaxel chemotherapy every three weeks, JS207 with JS004 antibody every three weeks, or JS207 alone at 10mgkg or another dose. These groups allow comparison of different combinations to explore potential benefits and safety profiles. During the study, participants will be monitored for tumor response, disease control, duration of response, progression-free survival, overall survival, and any adverse effects or laboratory abnormalities. These outcomes will be assessed over periods ranging from 1.5 to 2 years to gather comprehensive information about treatment effects and safety.

Langerhans cell histiocytosis LCH is a disorder mostly affecting children, caused by an abnormal buildup of Langerhans cells in body tissues. This disease varies widely in severity, with mild cases often resolving on their own and severe multisystem cases involving multiple organs like liver, spleen, or bone marrow, which can be life-threatening without proper treatment. Standard treatment includes prednisone and vinblastine chemotherapy, but some children develop resistance or relapse, leading to long-term health problems. This trial studies whether adding a targeted drug called luvometinib to chemotherapy can improve outcomes in children with multisystem LCH. Participants will be randomly assigned to receive either a modified standard chemotherapy regimen prednisone and vincristine alone or the same chemotherapy combined with oral luvometinib, a MEK12 inhibitor taken daily. The chemotherapy also includes mercaptopurine during maintenance. The study is conducted at multiple centers and aims to evaluate if the combination treatment improves patient outcomes compared to chemotherapy alone. During the trial, children will be closely monitored through clinical and imaging evaluations. Researchers will assess event-free survival over two years, responses at 1 and 3 months after treatment, overall survival, and any treatment-related side effects. Follow-up will include safety assessments and regular check-ups to track disease progression and treatment tolerance throughout the study period.

Researchers are studying 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 multi-center, open-label Phase III study aims to evaluate the safety, pharmacokinetics, and antitumor activity of MCLA-129. The study includes patients with tumors that have progressed after standard treatments or are intolerant to them. The study has two parts Part I involves dose escalation and dose expansion to determine safe and effective dose levels of MCLA-129 administered by intravenous infusion every one or two weeks. Part II is a cohort expansion phase assessing efficacy, safety, and pharmacokinetics at the recommended Phase II dose in groups of patients with specific biomarker profiles, such as EGFR mutations or MET amplification. Participants will receive MCLA-129 infusions in 28-day cycles and undergo regular assessments including tumor measurements, safety monitoring, and pharmacokinetic testing. Primary outcomes include dose-limiting toxicity, maximum tolerated dose, overall response rate, and treatment-emergent adverse events. Secondary outcomes measure drug levels, response duration, progression-free survival, and overall survival. Follow-up continues for approximately two years after treatment initiation to monitor effects and safety.

Researchers are evaluating the study drug sacituzumab govitecan SG Trodelvy GS-0132 IMMU 132 compared to standard of care SOC treatments in participants who have previously been treated for extensive stage small cell lung cancer ES-SCLC. The main goal is to compare how SG versus SOC affects overall survival OS in this population. This is a global, multicenter, randomized, open-label, phase 3 clinical trial focusing on treatment outcomes for ES-SCLC. Participants are randomly assigned to one of two groups. Treatment Group A receives sacituzumab govitecan intravenously at 10 mgkg on Days 1 and 8 of a 21-day cycle, continuing until disease progression, death, unacceptable toxicity, or other reasons for stopping treatment. Treatment Group B receives investigator-selected standard care options within a 21-day cycle, including topotecan given daily on Days 1 through 5, lurbinectedin as an intravenous infusion on Day 1 where approved, or in Japan, amrubicin daily on Days 1 through 3. Treatment continues under the same conditions as Group A. Participants will undergo regular assessments including imaging scans to measure disease status, laboratory tests, and monitoring for side effects. Researchers will evaluate overall survival for up to 4.5 years and secondary outcomes such as progression-free survival, response rates, duration of response, and effects on symptoms like shortness of breath and physical functioning. Safety will be tracked through adverse event reporting and laboratory abnormalities throughout the study duration.

Researchers are evaluating a new way to improve the diagnosis and treatment of lung cancer by creating synthetic PET images from CT scans. This method aims to keep important biological details and add clinical value by linking anatomical CT images with metabolic PET scans. The study is observational and takes place across multiple centers to validate the usefulness of this approach for lung cancer patients. Participants will undergo paired diagnostic CT and FDG-PET scans as part of their routine clinical care, with the PET-CT scan performed before starting systemic treatment for the tumor. The study focuses on analyzing these imaging data to develop a model that maps anatomical details to metabolic activity, without adding extra treatment or interventions. During the study, researchers will measure how closely the synthetic PET images match the real ones using metrics like structural similarity, peak signal-to-noise ratio, and metabolic parameter consistency. They will also assess the predictive performance of the model. The study runs from December 2025 to December 2026, involving patients with non-small cell lung cancer who consent to participate and have both CT and FDG-PET scans available.

The trial is a multicenter, randomized, open-label, positive-controlled phase III study enrolling 84 girls aged 2 to under 12 years with short stature due to Turner Syndrome TS. The study aims to compare the effectiveness and safety of two growth hormone treatments, Inpegsomatropin-Injection and Givopegsomatropin Solution Injection, to provide evidence supporting the new use of Inpegsomatropin in this population. Participants are randomly assigned in equal numbers to receive either Inpegsomatropin injection at 280 mcgkgweek or Givopegsomatropin solution injection at 200 mcgkgweek. Both treatments are administered subcutaneously once a week for 52 weeks. The study follows a parallel design to assess the comparative outcomes of these two drugs throughout the treatment period. During the study, children will be monitored regularly for growth velocity, changes in height standard deviation scores, insulin-like growth factor 1 levels, and bone age progression. Safety and efficacy will be evaluated at various follow-up points up to week 52. Guardians and participants aged 8 or older will provide informed consent or assent. The total participation time covers the full 52-week treatment and assessment period.