Jia Mu Si Shi

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating treatments for people with extensive stage small-cell lung cancer (ES-SCLC). This phase 3 study compares the effectiveness of adding tarlatamab to a combination of durvalumab, carboplatin, and etoposide against the combination without tarlatamab. The main goal is to see which treatment better prolongs overall survival and progression-free survival over about 3.5 years. Participants receive intravenous infusions of the study drugs. One group gets tarlatamab combined with durvalumab, carboplatin, and etoposide, while the other group receives durvalumab, carboplatin, and etoposide alone. All treatments are given as first-line therapy for their lung cancer. During the study, participants will be monitored regularly to assess their response to treatment and overall health. Researchers will measure overall survival and progression-free survival to evaluate treatment benefit. The study also involves ongoing safety monitoring, and participants will be followed for up to approximately 3.5 years to collect these outcomes.

Researchers are evaluating the safety, tolerability, how the body processes, and early anti-cancer effects of a new drug called BG-C477. The study includes participants with advanced solid tumors that have been previously treated or for whom no standard treatment exists. This trial is a Phase 1a/b, first-in-human study conducted by BeOne Medicines, formerly BeiGene, to better understand BG-C477 alone and combined with other cancer treatments. Participants will receive BG-C477 intravenously, either by itself or combined with other anticancer agents such as Tislelizumab or chemotherapy given according to local guidelines. The study includes dose escalation to find the maximum tolerated or administered dose, followed by dose expansion to evaluate recommended doses. This process may last up to approximately two years, with specific focus on safety, dosing, and preliminary effectiveness. During the study, participants will be monitored for side effects and treatment responses through clinical assessments, laboratory tests, and imaging to measure tumor changes. Researchers will collect samples from tumors and track adverse events from the first dose until 30 days after the last dose, with follow-up lasting up to two years. The primary outcomes include safety measurements, dose recommendations, and overall response rate to treatment.

Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.

Researchers are evaluating the safety and effectiveness of combining valemetostat tosylate with pembrolizumab compared to pembrolizumab alone in adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has no actionable genomic alterations and whose tumors show high PD-L1 expression (50% or greater). This trial includes participants who have not previously received systemic therapy for their advanced or metastatic NSCLC. The study is conducted in two phases: a dose escalation phase to find the recommended phase 2 dose, followed by a dose expansion phase to further assess treatment effects. Participants receive valemetostat tosylate orally once daily until the recommended dose is established. Pembrolizumab is given as an intravenous infusion on the first day of each 21-day cycle, for up to 35 cycles. The trial compares this combination treatment to pembrolizumab alone, administered on the same schedule. The study design is open-label and randomized, allowing comparison of both treatment approaches in this patient population. During the study, participants undergo regular assessments including imaging scans to measure disease progression and safety monitoring for side effects. Researchers track dose-limiting toxicities, treatment-related adverse events, and progression-free survival over approximately 31 months. Tumor tissue samples and biomarker analyses are collected to support evaluation. Participant physical status and eligibility are carefully assessed before and during the study. Follow-up includes monitoring for safety up to 30 days after the last dose and long-term evaluation of treatment impact.

Researchers are investigating whether Extract of Ginkgo Biloba Leaves Tablets can help improve thinking and memory in people aged 55 years and older who have had an ischemic stroke, which is caused by a blocked blood vessel in the brain. This phase 4 clinical trial is designed to assess both the effectiveness and safety of this treatment when added to the usual care for stroke recovery. Participants must have had a mild stroke confirmed by an MRI scan and show signs of cognitive impairment. The study takes place at multiple hospitals across China. Participants will be randomly assigned to one of two groups: one group will receive Extract of Ginkgo Biloba Leaves Tablets at a dose of 240 mg daily, divided into three doses of two 40 mg tablets each, along with their standard post-stroke care for 52 weeks. The other group will receive only the standard care recommended by the Chinese Stroke Association. The trial is open-label, meaning both the researchers and participants know which treatment is given. Throughout the year-long study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and testing. Researchers will evaluate changes in cognitive function using tests such as the Montreal Cognitive Assessment, Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency Test. They will also monitor neurological impairment and any new stroke events. Follow-up phone calls will occur at 12 and 38 weeks to support ongoing monitoring and safety assessments.

Researchers are evaluating the real-world effectiveness and safety of Trastuzumab Deruxtecan (T-DXd) in Chinese patients with unresectable or metastatic HER2-positive or HER2-low breast cancer. This multi-center prospective observational study focuses on patients who have previously received anti-HER2 therapies or systemic therapies in the metastatic setting, or those with disease recurrence shortly after adjuvant chemotherapy. The study aims to understand the time to next treatment or death, treatment patterns, patient characteristics, and safety in a real-world setting over a 36-month period. Participants will receive Trastuzumab Deruxtecan via intravenous infusion, starting treatment no more than 14 days before enrollment. The study includes patients with confirmed HER2-positive or HER2-low status who meet specific prior treatment criteria. Participants are followed from the day they begin T-DXd until the study ends, death, withdrawal, loss to follow-up, or study closure, whichever comes first. During the study, researchers will collect clinical data and patient-reported outcomes, including safety events reported by physicians and patient tolerability. The main measurement is the real-world time to next treatment or death. Additional assessments include time to treatment discontinuation, management of side effects, and patient questionnaires when possible. This comprehensive monitoring helps evaluate the overall impact of T-DXd treatment in this patient population.

Researchers are investigating the effects of art therapy on motor function recovery in patients who have experienced a subacute ischemic stroke. This phase, occurring within days to weeks after the stroke, is a crucial time for rehabilitation to improve functional outcomes and long-term recovery. The study focuses on patients aged 40 to 75 who are in the subacute phase of stroke recovery, aiming to understand how art therapy might support brain plasticity and motor function improvement compared to standard treatment. The study compares art therapy, which includes activities such as music, painting, and dance designed to regulate emotions and activate brain areas to promote neuroplasticity, with regular standard therapy. Participants will engage in these interventions during the subacute recovery phase, which ranges from 2 weeks to 3 months after stroke onset. Art therapy sessions involve creative activities that may help reduce anxiety and depression while aiding motor function rehabilitation. Participants will be monitored through assessments including the Fugl-Meyer Assessment one month after intervention to evaluate motor function recovery. The study requires participants to have mild to moderate stroke sequelae, basic cognitive and communication abilities, and the physical capacity to participate in art therapy activities. Researchers will also monitor emotional status, adherence to treatment sessions, and overall rehabilitation progress during the study period to measure the effects and safety of art therapy in this patient group.