Santa Lucia

Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab for adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma. This study focuses on the dual targeting of EGFR and TGF-beta, which contribute to tumor growth and spread. It includes both phase 2 and phase 3 parts to identify the best dose and to compare treatment outcomes. In phase 2, participants are randomized into three groups receiving either higher or lower doses of ficerafusp alfa plus pembrolizumab, or placebo plus pembrolizumab. In phase 3, participants receive the selected optimal biologic dose of ficerafusp alfa with pembrolizumab or placebo with pembrolizumab in a 21 ratio. Treatments are given weekly or every three weeks depending on the drug, with careful monitoring throughout the study. Participants will undergo tumor biopsies or provide archival tissue, and receive regular assessments including imaging scans and lab tests to measure tumor response and safety. Researchers will track side effects, response rates, survival, and quality of life using standardized criteria over approximately 1 to 3 years. Safety monitoring continues up to 90 days after treatment ends. The total study duration extends through long-term follow-up to evaluate overall outcomes.

Researchers are evaluating the study drug sacituzumab govitecan SG Trodelvy GS-0132 IMMU 132 compared to standard of care SOC treatments in participants who have previously been treated for extensive stage small cell lung cancer ES-SCLC. The main goal is to compare how SG versus SOC affects overall survival OS in this population. This is a global, multicenter, randomized, open-label, phase 3 clinical trial focusing on treatment outcomes for ES-SCLC. Participants are randomly assigned to one of two groups. Treatment Group A receives sacituzumab govitecan intravenously at 10 mgkg on Days 1 and 8 of a 21-day cycle, continuing until disease progression, death, unacceptable toxicity, or other reasons for stopping treatment. Treatment Group B receives investigator-selected standard care options within a 21-day cycle, including topotecan given daily on Days 1 through 5, lurbinectedin as an intravenous infusion on Day 1 where approved, or in Japan, amrubicin daily on Days 1 through 3. Treatment continues under the same conditions as Group A. Participants will undergo regular assessments including imaging scans to measure disease status, laboratory tests, and monitoring for side effects. Researchers will evaluate overall survival for up to 4.5 years and secondary outcomes such as progression-free survival, response rates, duration of response, and effects on symptoms like shortness of breath and physical functioning. Safety will be tracked through adverse event reporting and laboratory abnormalities throughout the study duration.