Hemer

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are studying the clinical and health-related outcomes of treatments containing amivantamab for people with common EGFR-mutated advanced non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. This type of cancer can spread to other parts of the body and occurs due to changes in genes such as the epidermal growth factor receptor (EGFR). The study focuses on real-world use of these treatments outside of controlled clinical trials. Participants will receive amivantamab-containing regimens as part of their standard care, decided by their doctors according to approved guidelines and local recommendations for supportive medications. The study observes patients starting these treatments for the first time and follows their clinical course as they receive care in usual medical settings. During the study, researchers will collect data for up to approximately 60 months to understand how long patients continue treatment and other health outcomes. Data collection includes monitoring treatment use, clinical responses, and safety in a real-world context. Participants or their representatives must provide consent for data verification, and the study tracks outcomes during routine clinical visits without altering standard treatment practices.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer (NSCLC) who have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are evaluating a treatment strategy for patients with stage IIIB or IV non-small cell lung cancer (NSCLC) who have specific EGFR mutations (L858R or Ex19del) and are newly starting osimertinib therapy. The study aims to see if adding platinum-based chemotherapy to osimertinib can improve progression-free survival (PFS) compared to historical data of osimertinib alone, especially in patients who show persistent EGFR mutations in their blood after 3 weeks of osimertinib treatment, indicating a potentially poor response to the single-agent therapy. Participants begin with osimertinib at 80 mg daily or a reduced dose of 40 mg daily for about 7 weeks. Those who still have detectable EGFR mutations in their plasma at 3 weeks will have their treatment escalated by adding up to four cycles of chemotherapy consisting of pemetrexed combined with either cisplatin or carboplatin, administered intravenously every 21 days. Patients without detectable EGFR mutations continue with standard osimertinib treatment and are not part of the escalation phase. During the study, participants undergo regular assessments including liquid biopsies to monitor EGFR mutation levels, imaging scans such as chest and abdominal CT or MRI, and clinical evaluations including ECOG performance status. Researchers measure progression-free survival over two years to assess treatment effectiveness. Safety and side effects are closely monitored throughout, with follow-up visits scheduled during and after treatment. The total involvement includes pre-screening, treatment phases, and ongoing monitoring to understand treatment impact and tolerability.

Researchers are evaluating the AeriSeal System in patients with severe, heterogeneous emphysema who have collateral ventilation (CV) in the lung lobe targeted for treatment. This multi-center, prospective trial aims to enroll 200 subjects who are candidates for bronchoscopic lung volume reduction (BLVR). The study focuses on converting CV status from positive to negative using the AeriSeal System, with follow-up for 24 months to assess safety and effectiveness. Participants will undergo a bronchoscopy procedure under general anesthesia to confirm CV status using the Chartis Pulmonary Assessment System. Those with positive CV status will receive the AeriSeal Foam delivered bronchoscopically to the target lung lobe. If CV status remains positive 45 days after the initial treatment, a repeat AeriSeal procedure may be performed, with a maximum total foam volume of 40 mL across up to three segments. Subjects who convert to negative CV status after either the initial or repeat procedure will then undergo BLVR with the Zephyr Valve and be followed for 24 months. Subjects who remain CV positive will also be followed for 24 months. During the study, participants will have their CV status assessed at Day 45 post-treatment as the primary outcome. Researchers will monitor safety, lung function, and clinical symptoms throughout the two-year follow-up. Assessments include imaging, pulmonary rehabilitation status, symptom scores, and lung function tests. The study tracks responder rates and conversion of CV status to evaluate the potential benefit of the AeriSeal System in facilitating BLVR treatment.

Researchers are evaluating bronchoscopic lung volume reduction using thermoablation as a treatment for patients with severe emphysema. This prospective, randomized, open-label clinical trial compares this interventional procedure to the usual conservative standard therapy guided by GOLD guidelines. The study aims to provide evidence supporting this procedure as an effective and safe treatment option to improve care for emphysema patients based on current medical knowledge. The treatment involves using the InterVapor® System, which applies heated water vapor to ablate targeted lung regions. This process triggers lung remodeling through inflammation and healing, reducing tissue and air volume in diseased lung areas. The resulting lung volume reduction is expected to improve lung function, exercise capacity, and quality of life by decompressing healthier lung segments and enhancing respiratory muscle efficiency. Participants will be monitored for changes in patient-reported disease-specific quality of life over 9 months. The study includes assessments such as pulmonary function tests, high-resolution CT scans, blood gas measurements, dyspnea scoring, and a 6-minute walk test. Researchers will also evaluate safety and treatment effects through follow-up visits, with total participation lasting at least 9 months to track outcomes and any adverse events.