Lowenstein

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

Researchers are evaluating the combination of BMS-986504, pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in people with first-line metastatic non-small cell lung cancer who have a homozygous MTAP deletion. The study is a randomized phase 2/3 trial focused on assessing clinical benefits in this specific patient group. Participants will receive either BMS-986504 with pembrolizumab and chemotherapy or placebo with pembrolizumab and chemotherapy. The chemotherapy may include drugs such as cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on specified days. This treatment is administered as part of the first-line therapy for metastatic disease. During the study, researchers will monitor progression-free survival up to 2 and 5 years using RECIST v1.1 criteria and overall survival up to 5 years. Participants will be assessed regularly for disease progression and survival outcomes. The study includes detailed monitoring to evaluate the effects and safety of the treatment combination over time.

Researchers are investigating the safety and effectiveness of Dato-DXd combined with osimertinib or alone compared to platinum-based doublet chemotherapy in treating adults with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase III, open-label study includes participants whose disease has worsened despite prior osimertinib treatment. The goal is to evaluate progression-free survival (PFS) over up to 2.5 years. Participants are randomly assigned to one of three groups: Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd and chemotherapy drugs (pemetrexed, carboplatin, or cisplatin) are given by intravenous infusion, while osimertinib is taken orally. Treatment continues until the cancer progresses based on imaging, unacceptable side effects occur, or other reasons require stopping treatment. After stopping the study drugs, participants will have an end-of-treatment visit within 35 days and safety follow-up about one month later. During the trial, researchers will monitor participants with radiological scans and assess progression-free survival. Safety evaluations will continue after treatment ends to detect any side effects. The study includes adults aged 18 to 130 years with good performance status and adequate organ function who have progressed on prior osimertinib therapy. The total study duration includes treatment and follow-up periods to ensure thorough assessment of treatment effects and safety.

Researchers are evaluating digital mobility outcomes to monitor treatment and disease progression in adults with pulmonary hypertension. The study aims to find out if digital measures of walking behavior correlate with pulmonary arterial pressures measured by right heart catheterization. This observational trial focuses on adult patients diagnosed with precapillary pulmonary hypertension. Participants will wear a small accelerometer device on their lower back for one week at a time, three times in total: at diagnosis, and during follow-up visits at 3-6 months and again at 6-12 months. The sensor device is fixed with waterproof plasters and does not provide feedback or display data to the participant while worn. Follow-up visit timing is determined by the treating clinician. During the study, participants will undergo baseline and follow-up assessments, including right heart catheterization to measure pulmonary arterial pressure. The device collects real-world walking activity data during each one-week period. Researchers will analyze correlations between the digital mobility data and pulmonary pressure measurements. Participants may choose to receive feedback on their sensor data after the study ends.

Researchers are evaluating the safety and effectiveness of Tumor Treating Fields (TTFields) delivered by the NovoTTF-200T device combined with pembrolizumab and platinum-based chemotherapy for patients with metastatic non-small cell lung cancer (NSCLC) that has spread to other parts of the body. This Phase 3 randomized study aims to compare overall survival and progression-free survival between patients receiving this combination treatment and those receiving pembrolizumab with platinum-based chemotherapy alone. Additional analysis will examine outcomes based on lung cancer subtype and PD-L1 expression levels. The NovoTTF-200T is a portable, battery-operated device designed for continuous home use that emits electric fields to disrupt cancer cell division. Participants will receive this device alongside pembrolizumab, an immune checkpoint inhibitor, and standard platinum-based chemotherapy. The study will stratify patients by cancer histology, PD-L1 expression, and previous immunotherapy treatment. Treatments will be given according to the study protocol at approximately 130 sites globally. Participants will be monitored for up to six years to assess overall survival and progression-free survival using standardized criteria. The study includes regular evaluations of tumor response, safety, and other clinical outcomes. Participants must have good performance status and adequate organ function to join. The research team will collect data on cancer progression and survival to better understand the potential benefits and risks of adding TTFields to standard therapies for metastatic NSCLC.

Researchers are collecting detailed, real-world information over time about people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called METex14 skipping alteration. This study aims to understand how treatments for this type of lung cancer are used and how well they work and how safe they are in everyday clinical practice across multiple countries. It is a disease registry that observes patients without changing their treatment plans. Participants in this registry will continue to receive their usual cancer treatments as decided by their doctors, with no additional procedures or therapies imposed by the study. The registry gathers data on each participant's demographics, clinical features including biomarker information, treatment patterns, and outcomes related to effectiveness and safety. The study is non-interventional, meaning treatments are not assigned by the study but follow routine clinical care. Throughout the study, researchers will monitor and record best overall tumor response, tumor response using standard criteria (RECIST 1.1), overall survival, and the number of participants experiencing adverse events or reactions. This data collection will continue for up to approximately 4.9 years, enabling long-term follow-up of outcomes and safety in this patient population.

Researchers are evaluating the long-term safety of nivolumab monotherapy, including its use with combinations and other cancer treatments, in patients with various types of cancer. This Phase 2 study focuses on patients who have previously participated in Bristol-Myers Squibb (BMS) sponsored trials involving nivolumab and other cancer therapies. The goal is to gather information on safety over an extended period following treatment. Participants may receive nivolumab alone or alongside other cancer drugs such as ipilimumab, cabozantinib, trametinib, relatlimab, capecitabine, bevacizumab, and others. Each drug is given at specified doses on designated days according to the study protocol. Treatment continuation or rechallenge is based on the participant's status from their prior parent study, including treatment holds after lasting responses or eligibility for restarting treatment. During the study, participants will be closely monitored for adverse events, including general, drug-related, serious, immune-mediated, and select adverse effects, as well as any deaths, from the start of treatment until 135 days after stopping treatment. Safety assessments and clinical evaluations will be conducted regularly to track these outcomes and ensure participant well-being throughout the trial.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are studying severe asthma through the German Asthma Net e.V., which focuses on improving medical care and understanding of this condition. Since there is limited reliable data on how often severe asthma occurs, its characteristics, and treatment patterns, this clinical registry collects detailed information from patients across Germany. The aim is to better characterize severe asthma by gathering data from multiple clinics and practices, helping to optimize diagnosis and treatment over time. Participants in this registry have their sociodemographic details and medical information recorded, including diagnosis, therapy, lung function, laboratory values like IgE and eosinophil granulocytes, asthma symptoms, medication use, smoking status, and additional treatments. This data is collected at a baseline visit and then annually for up to 15 years. Each participant receives a unique study ID to protect privacy, with personal and health data stored securely on separate servers. During the study, patients will be regularly monitored for asthma symptom control, with assessments at baseline, four months, and yearly thereafter for up to 15 years. Researchers will track symptoms, medication use, exacerbations, lung function, and laboratory markers to better understand severe asthma's course and treatment outcomes. This long-term follow-up aims to improve care by providing robust data on severe asthma patients.