Lebanon

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating whether a new medicine called PF-08634404 combined with chemotherapy is more effective than the current standard treatment, pembrolizumab with chemotherapy, for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 3 study focuses on adults 18 years and older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and have not received prior treatment for advanced disease. The study excludes participants with known actionable genomic alterations and aims to compare overall survival and progression-free survival over approximately 39 and 32 months, respectively. Participants are assigned to two parts based on their tumor type: squamous NSCLC patients in Part 1 and non-squamous NSCLC patients in Part 2. Within each part, participants are randomly assigned to receive either the experimental treatment PF-08634404 or the control treatment pembrolizumab, each combined with a chemotherapy regimen tailored to tumor type. Treatments are given via intravenous infusions in cycles, followed by maintenance therapy with either monotherapy or combination therapy depending on the study part. Treatment continues as long as it is beneficial and side effects remain manageable. During the study, participants will have regular visits for treatment administration and health evaluations. Cancer response will be monitored with tests every 6 weeks for the first 48 weeks and then every 12 weeks afterward. Researchers will assess overall survival and progression-free survival, ensuring thorough monitoring of participants' health and treatment effects throughout the study period.

Researchers are conducting a phase 3, multicenter, randomized, open-label study to compare treatments in patients with metastatic non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitor (ICI) therapy. The study focuses on patients positive for the HLA-A2 phenotype and includes both squamous and non-squamous types of NSCLC. Participants will be grouped based on cancer histology and their performance status to better understand treatment effects. Participants will be randomly assigned in a 2:1 ratio to receive either the experimental treatment OSE2101 or the standard treatment docetaxel. OSE2101 is a cancer vaccine made of nine specific peptide components targeting tumor-associated antigens, combined with an adjuvant to enhance immune response. Docetaxel, the control treatment, is a chemotherapy drug that disrupts cell division. The study uses an assay device to confirm HLA-A2 status before treatment allocation. During the average three-year study period, researchers will monitor overall survival, defined as the time from randomization until death. Patients will be regularly assessed for treatment response and safety. The trial aims to gather important data on the efficacy and tolerability of the OSE2101 vaccine compared to docetaxel in this patient population with metastatic NSCLC and secondary resistance to ICI therapy.