Kryvyi Rih

Researchers are evaluating new treatments for locally advanced non-small cell lung cancer NSCLC that cannot be surgically removed and has a specific gene mutation called KRAS G12C. This trial aims to find out if the combination of calderasib MK-1084 and durvalumab can help participants live longer without their cancer growing or spreading compared to durvalumab with a placebo after they have completed chemotherapy and radiation therapy. Participants will be randomly assigned to receive either calderasib along with durvalumab or a placebo along with durvalumab. Calderasib is taken by mouth as a tablet, and durvalumab is given as an intravenous infusion. This study is double-blinded, meaning neither the participants nor the researchers know who receives the active drug or placebo. The treatment period will be followed by long-term monitoring. During the study, participants will have various assessments including survival monitoring up to approximately 9 years, evaluations of adverse events, response rates, and quality of life questionnaires. Researchers will also collect tumor tissue samples for biomarker analysis. The main measurement is progression-free survival, checked for up to about 6 years. Participants health and side effects will be closely tracked throughout and after treatment.

Researchers are evaluating the effectiveness and safety of combining calderasib with pembrolizumab as the first treatment for people 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. The study compares this combination to pembrolizumab with a placebo to see if it improves the time participants live without the cancer worsening and overall survival. Participants receive pembrolizumab through an intravenous infusion every 21 days for up to 35 cycles. They also take calderasib or a matching placebo by mouth daily until they meet criteria to stop treatment. The study is randomized and double-blind, meaning neither participants nor researchers know who receives calderasib or placebo. During the study, participants will have regular assessments to monitor cancer progression, overall survival, response rate, and quality of life measures through questionnaires. Safety will be closely monitored by tracking adverse events and treatment discontinuations. The study may last up to about 56 months, including follow-up to observe long-term outcomes and quality of life changes.

Researchers are evaluating a study medicine called MK-1084 for treating advanced or metastatic nonsquamous Non-Small Cell Lung Cancer NSCLC with a specific KRAS G12C gene mutation. This phase 2 randomized trial aims to assess the safety of MK-1084 and how well it might shrink or eliminate tumors in people with this type of lung cancer. The study is sponsored by Merck Sharp & Dohme LLC and focuses on targeted therapy for this genetic mutation in cancer cells. Participants are randomly assigned to one of three treatment groups one group receives Pembrolizumab plus MK-1084 another group receives Pembrolizumab, MK-1084, and Cetuximab and the third group receives Pembrolizumab, MK-1084, and sacituzumab tirumotecan sac-TMT. Pembrolizumab is given every 6 weeks intravenously, Cetuximab and sac-TMT are administered every 2 weeks intravenously, and MK-1084 is given orally according to a dosing regimen. Rescue medications are provided to prevent infusion reactions and oral side effects. During the study, participants are monitored for dose limiting toxicities, adverse events, and discontinuations due to side effects over up to 84 months. Tumor response is measured using RECIST 1.1 criteria reviewed independently. Blood samples will be taken at designated times to study MK-1084 concentrations. Researchers will also track duration of response, progression-free survival, and overall survival. The study involves regular visits for treatment administration and safety assessments throughout the trial period.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the effectiveness of adjuvant calderasib combined with subcutaneous pembrolizumab and berahyaluronidase alfa MK-3475A compared to placebo plus MK-3475A in participants with completely resected stage IIA-IIIB N2, KRAS G12C-mutant non-small cell lung cancer. This phase 3, randomized, double-blind study focuses on participants who have received either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy, aiming to improve disease-free survival. Participants are randomly assigned to receive either calderasib daily along with MK-3475A every 6 weeks for up to 9 doses, or placebo daily plus MK-3475A on the same schedule. The study compares these two groups to assess their effects on disease progression. The treatment period involves regular dosing and monitoring over time. During the study, participants will be monitored for disease-free survival for up to approximately 11 years. Researchers will also assess overall survival, distant metastasis-free survival, lung cancer-specific survival, and changes in quality of life using validated questionnaires. Safety will be checked through reports of adverse events and treatment discontinuations over an extended follow-up period of up to about 13.5 years.