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Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

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 do not achieve a complete response after initial therapy. This Phase 3 trial compares the combination of sacituzumab tirumotecan plus pembrolizumab against pembrolizumab alone, focusing on disease-free survival assessed by a blinded independent central review. The study is sponsored by Merck Sharp & Dohme LLC and targets participants with specific stages of NSCLC who have undergone neoadjuvant therapy and surgery but still have residual disease. Participants first receive neoadjuvant therapy consisting of pembrolizumab combined with double-platinum chemotherapy tailored to the tumor type for up to 12 weeks before surgery. After surgery, those not achieving pathological complete response are assigned to either receive sacituzumab tirumotecan infusions every two weeks for up to 24 weeks alongside pembrolizumab monotherapy every six weeks for approximately 42 weeks, or pembrolizumab monotherapy alone on the same schedule. Rescue medications to manage infusion reactions may be given as needed during the study. Throughout the trial, participants undergo assessments including radiological scans, tumor tissue analysis for markers like PD-L1 and TROP2, and monitoring for adverse events and quality of life changes. Key outcomes include disease-free survival, overall survival, distant metastasis-free survival, and lung cancer-specific survival, with evaluations continuing for up to nearly 10 years. Safety and tolerability are closely monitored, and questionnaires assess physical functioning, symptoms like cough and chest pain, and overall health status during and after treatment.

Researchers are evaluating the efficacy and safety of arlo-cel BMS-986393, a GPRC5D-directed CAR-T cell therapy, compared to standard treatment regimens in adults with relapsed or refractory multiple myeloma who have been exposed to lenalidomide. This Phase 3 study aims to better understand how this new therapy performs in this patient group and may provide important insights into treatment options for this condition. Participants will be randomly assigned to receive either the investigational CAR-T cell therapy arlo-cel or one of the standard treatment regimens, which may include drugs such as Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, or Carfilzomib. The investigational therapy involves specified doses given on specific days. The study is open-label, multicenter, and will follow participants over time to assess outcomes. During the study, participants will be monitored for progression-free survival and minimal residual disease negativity for up to five years after the last participant is enrolled. Additional outcomes include overall survival, response rates, quality of life changes, and drug concentration levels. Researchers will conduct regular assessments including clinical evaluations and laboratory tests to gather these data. The total participation may last several years to fully capture long-term effects and safety.

Researchers are evaluating pembrolizumab combined with carboplatin and taxane chemotherapy as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC. This phase 3 trial aims to compare overall survival between patients receiving pembrolizumab with maintenance sacituzumab tirumotecan sac-TMT and those receiving pembrolizumab alone during maintenance therapy. The study explores whether the addition of sac-TMT improves outcomes for patients with this type of lung cancer. Participants first undergo an induction phase of four cycles receiving pembrolizumab every 3 weeks along with carboplatin and either paclitaxel or nab-paclitaxel. After induction, they are randomly assigned to one of two maintenance groups pembrolizumab alone every 6 weeks for up to 96 weeks, or pembrolizumab combined with sac-TMT every 2 weeks until discontinuation criteria are met. The chemotherapy drugs are given intravenously during the induction phase, and maintenance treatments continue intravenously according to assigned groups. Throughout the study, participants will be monitored for overall survival as the primary outcome, with secondary outcomes including progression-free survival, adverse events, treatment discontinuations, and quality of life measures such as dyspnea, cough, and chest pain. Assessments include tumor scans to evaluate disease status, performance status checks, and patient-reported questionnaires on symptoms and health-related quality of life. Participants are followed for up to approximately 79 months to gather comprehensive safety and efficacy data, with ongoing monitoring by the research team.

Researchers are comparing the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone for people with metastatic non-small cell lung cancer NSCLC who have high PD-L1 expression 50% or more. The study aims to see if the combination improves overall survival compared to pembrolizumab by itself. This is a Phase 3 clinical trial focusing on first-line treatment in this patient group. Participants receive either sacituzumab tirumotecan plus pembrolizumab or pembrolizumab alone. Sacituzumab tirumotecan is given by intravenous infusion on Days 1, 15, and 29 of each 6-week cycle, while pembrolizumab is given by intravenous infusion every 6 weeks for up to 18 cycles. Supportive medications such as diphenhydramine, acetaminophen, dexamethasone, and H2 antagonists are used before some infusions to manage side effects. Participants who complete the first pembrolizumab course and show disease progression may be eligible for additional pembrolizumab cycles. Throughout the trial, participants will have regular assessments including scans and evaluations to measure overall survival and other outcomes such as progression-free survival, tumor response, and quality of life. Researchers will also monitor symptoms like cough, chest pain, and breathing difficulties. Safety is closely followed over up to approximately 77 months, with detailed data collected on adverse events and treatment discontinuation. The total participation duration can last several years depending on individual progress and treatment response.

Researchers are evaluating how a new combination treatment of Sigvotatug Vedotin plus pembrolizumab works compared to pembrolizumab alone in adults with non-small cell lung cancer NSCLC who have high levels of the PD-L1 protein. This protein can limit the bodys immune response to cancer. The study includes participants with advanced NSCLC who meet specific molecular and staging criteria and aims to assess the treatments effects on survival and disease progression. Participants receive pembrolizumab as an intravenous infusion once every 6 weeks at the clinic. Half of the participants will also receive Sigvotatug Vedotin intravenously every 2 weeks alongside pembrolizumab. Pembrolizumab treatment may continue for up to about two years, whereas Sigvotatug Vedotin administration can continue until the cancer no longer responds. The trial is randomized and controlled, comparing the combination treatment to pembrolizumab alone. During the study, participants attend regular clinic visits for treatment and monitoring. Researchers will evaluate overall survival and progression-free survival over approximately two years, along with additional measures such as response rates, duration of response, safety, and drug levels in the blood. The study includes ongoing assessments to observe how participants respond to treatment and manage side effects, with a total participation time that may extend up to several years.