Ikata

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating whether olomorasib combined with pembrolizumab or durvalumab is more effective than these immunotherapies alone in participants with KRAS G12C-mutant non-small cell lung cancer NSCLC. The study focuses on two groups those with resected NSCLC and those with unresectable NSCLC. This Phase 3 trial aims to assess disease-free survival and progression-free survival among these participants over an estimated period of up to 3 years. Participants will receive either olomorasib or a placebo orally along with pembrolizumab or durvalumab administered intravenously for up to one year. After this combination phase, participants continue with olomorasib or placebo alone for up to a total of three years of treatment. The study includes randomized, double-blind groups to compare these combinations in both resected and unresectable NSCLC. During the study, participants undergo regular assessments to monitor disease progression, overall survival, and quality of life using questionnaires and imaging. Researchers measure outcomes such as disease-free survival, progression-free survival, response rates, and symptom changes related to NSCLC. The study also tracks safety and health impacts over the treatment period, which may last up to three years for each participant.