Kryvyi Rih

Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults 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. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.

Researchers are investigating whether the study drug MK-1084 can help treat advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that has a specific gene change called KRAS G12C. The study aims to evaluate the safety of MK-1084 and to find out how many participants experience tumor shrinkage or disappearance during treatment. This is a phase 2 randomized study focused on first-line treatment for this lung cancer type. Participants receive a combination of treatments including MK-1084 taken by mouth, and several intravenous drugs such as pembrolizumab, cetuximab, carboplatin, and pemetrexed. The study involves multiple treatment arms and closely monitors how patients respond to these therapies. Treatments are given according to a schedule determined by the study protocol, with careful attention to dosage and administration methods. During the trial, participants undergo regular assessments including monitoring for side effects, safety evaluations, and tumor response measurements using standard criteria. Researchers measure outcomes such as dose limiting toxicities, adverse events, treatment discontinuations due to side effects, and objective response rates over a period that may last up to approximately 84 months. Participants are followed closely throughout the study to ensure safety and to collect comprehensive data on treatment effects.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

Researchers are evaluating a phase 3, randomized, double-blind study comparing adjuvant calderasib plus a fixed dose coformulated product of pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475A. The study focuses on participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer who have previously received either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The main purpose is to assess disease-free survival (DFS) over up to approximately 11 years as determined by the investigator. Participants will be assigned to receive either oral calderasib tablets along with subcutaneous MK-3475A injections or oral placebo tablets with MK-3475A injections. Treatment involves the use of an oral tablet form of calderasib or placebo, alongside a subcutaneous injection of the coformulated pembrolizumab and berahyaluronidase alfa. The study includes an initial treatment phase following surgery and prior chemotherapy or neoadjuvant therapy. During the study, participants will undergo regular monitoring including radiological assessments such as contrast-enhanced chest or abdomen CT scans or MRI within 28 days before randomization. Researchers will evaluate disease status, safety, and performance status throughout the trial. Monitoring will include tracking disease-free survival, safety, and tolerability over a long follow-up period lasting up to around 11 years.