Matosinhos

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim. Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period. Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity FVC, over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatments long-term safety and effects.

Researchers are evaluating rilvegostomig compared with pembrolizumab monotherapy as a first-line treatment for people with metastatic non-small cell lung cancer mNSCLC whose tumors have high PD-L1 expression. This Phase III, global, randomized, and double-blind study aims to assess the efficacy and safety of these treatments in this patient population. The trial is sponsored by AstraZeneca and focuses on patients with specific tumor characteristics and no certain genetic mutations. Participants will receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study has two treatment arms one for the investigational drug rilvegostomig and one for the active comparator pembrolizumab. Both treatments are given as monotherapy to understand their effects as initial therapy in this cancer setting. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately 5 years. Additional assessments include tumor response, duration of response, time to second progression or death, drug pharmacokinetics, immunogenicity, and patient-reported outcomes related to physical function, quality of life, and lung cancer symptoms. The study involves regular evaluations to track treatment effects and safety over an extended period.

Researchers are comparing the effectiveness of a combination treatment including tarlatamab, durvalumab, carboplatin, and etoposide to a similar combination without tarlatamab in people with untreated extensive stage small-cell lung cancer ES-SCLC. This Phase 3 study aims to see if adding tarlatamab can improve overall survival and progression-free survival in this patient group. The study is sponsored by Amgen and focuses on first-line treatment options for this aggressive cancer stage. Participants are assigned randomly to one of two groups. One group will receive tarlatamab combined with durvalumab, carboplatin, and etoposide for four cycles, followed by maintenance treatment with tarlatamab and durvalumab. The other group receives durvalumab, carboplatin, and etoposide for four cycles, followed by durvalumab alone. All drugs are given through intravenous infusions. The study is open-label, meaning both participants and researchers know which treatment is being given. During the study, participants will be monitored up to approximately 3.5 years for overall survival and progression-free survival through blinded independent central review. Additional outcomes like objective response, disease control, duration of response, and treatment-related side effects will be tracked for up to four years. Blood samples will be taken to measure tarlatamab levels and to check for antibodies against the drug. Safety and treatment effects are carefully recorded throughout the study period.

Researchers are studying two combination treatments as front-line therapies for adults with stage IV or advanced stage IIIBC nonsquamous non-small cell lung cancer NSCLC that carries a KRAS p.G12C mutation and is negative for PD-L1. This phase 3 trial compares progression-free survival and overall survival in participants receiving either sotorasib with platinum doublet chemotherapy or pembrolizumab with platinum doublet chemotherapy. The goal is to evaluate which treatment combination may better manage this specific lung cancer type. Participants receive one of two treatment combinations sotorasib taken orally with carboplatin and pemetrexed, or pembrolizumab given intravenously with carboplatin and pemetrexed. These therapies are administered as front-line treatments. The study is randomized and open-label, meaning participants are assigned to a treatment group by chance and both participants and researchers know which treatment is given. During the study, participants will be monitored regularly for disease progression and survival over approximately 2.5 years. Additional assessments include quality-of-life questionnaires focusing on symptoms like dyspnea, cough, and chest pain, as well as physical function and global health status up to week 12. Safety is evaluated by tracking adverse events, vital signs, and laboratory test changes throughout the study, which may last up to about 5.5 years including follow-up. Participants receive care under medical supervision while contributing to important research on lung cancer treatment.

Researchers are evaluating whether baricitinib can delay the onset of clinical type 1 diabetes T1D in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study focuses on participants aged 1 to under 36 years who have early-stage T1D or related autoantibody markers. The goal is to understand if baricitinib can postpone the progression to stage 3 T1D over a study period lasting up to approximately five years. Participants will be randomly assigned to receive either baricitinib or a placebo, both taken orally. The study includes a double-blind design, meaning neither participants nor researchers know who is receiving the active drug or placebo. The research team will monitor participants for up to about five years to assess the time it takes to develop stage 3 T1D and other health measures. Throughout the study, participants will undergo various assessments including measurements of glucose-stimulated C-peptide, glucose levels, body measurements such as height and BMI percentile, and health surveys. Blood samples will be collected to analyze baricitinib levels and its effects on glucose metabolism. The primary outcome is the time from baseline until diagnosis of stage 3 T1D. Safety and health status will be closely observed during the study period.

Researchers are evaluating camizestrant, an oral selective estrogen receptor degrader, compared to standard endocrine therapy in patients with early-stage ER-positive, HER2-negative breast cancer. This Phase III open-label study focuses on individuals at intermediate or high risk for disease recurrence who have completed locoregional therapy and at least 2 years, up to 5 years, of standard adjuvant endocrine therapy. The goal is to assess if camizestrant improves invasive breast cancer-free survival and other related outcomes. Participants are randomly assigned to receive either camizestrant or continue with standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors such as exemestane, letrozole, anastrozole, or tamoxifen. Treatment duration for both groups is planned for 60 months 5 years. The study allows prior use of CDK46 inhibitors and excludes patients with specific medical conditions or prior use of similar investigational agents. During the study, patients will be regularly monitored for invasive breast cancer-free survival, invasive disease-free survival, distant relapse-free survival, overall survival, and safety measures, including adverse events and changes in laboratory and vital signs. Quality of life assessments related to symptoms like arthralgia, hot flushes, and vaginal dryness will also be conducted. Follow-up for participants will continue for up to 10 years from the last patients randomization.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves outcomes for adults with resectable non-small cell lung cancer NSCLC who did not achieve a complete response from initial treatment. This Phase 3 study compares combined sacituzumab tirumotecan plus pembrolizumab therapy to pembrolizumab alone to see which better supports disease-free survival. The trial focuses on participants with stage II to IIIB NSCLC who have undergone neoadjuvant pembrolizumab and platinum-based chemotherapy followed by surgery. Participants first receive pembrolizumab intravenously every 3 weeks with double-platinum chemotherapy for up to 12 weeks before surgery. After surgery, one group receives sacituzumab tirumotecan infusions every 2 weeks for up to 24 weeks alongside pembrolizumab infusions every 6 weeks for about 42 weeks. The comparison group receives pembrolizumab alone every 6 weeks for up to 7 cycles post-surgery. Rescue medications may be given to manage infusion reactions or mouth sores as needed. During the study, participants undergo regular evaluations including imaging scans to confirm disease status and laboratory tests to monitor health. Researchers assess disease-free survival as the primary outcome over up to about 93 months, alongside secondary measures such as overall survival, metastasis-free survival, lung cancer-specific survival, adverse events, and quality of life changes over up to 118 months. The study includes careful safety monitoring and long-term follow-up to understand treatment effects and participant wellbeing.

Researchers are studying IPN10200 to evaluate its safety and effectiveness in treating adults with upper limb spasticity caused by stroke or traumatic brain injury. This integrated Phase III study aims to understand how different doses of IPN10200 affect patients and to find the doses that balance the best effects with safety. The trial is double-blind, randomized, and includes comparisons with Dysport and placebo treatments to provide thorough evaluation. The study involves several stages, starting with dose escalation where participants receive a single injection of IPN10200, Dysport, or placebo in increasing doses across groups. Later stages test two fixed doses of IPN10200 injected into various upper limb muscles. Participants are randomly assigned to different groups in ratios such as 332 or 21 depending on the stage. Each participant receives a single local injection tailored to their assigned dose group. During the trial, participants will be monitored for up to 9 months to assess safety through adverse events, vital signs, lab tests, and antibody presence. Researchers will also measure treatment effects using the Modified Ashworth Scale to evaluate muscle spasticity changes, patient and physician global assessments, pain reduction, and disability scores. Follow-up includes regular evaluations of muscle tone, treatment response timing, and overall function to understand IPN10200s impact and safety profile.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.