PD-1 Blockade Alone Versus in Combination With Chemotherapy as First Line Therapy in Females With Advanced NSCLC & PD-L1 Expression ≥50%

While documented gender differences exist in drug efficacy and safety, men and women are often treated equally due to the absence of gender-specific clinical trials and approvals. Immune checkpoint blockade is used to enhance the immune system\'s ability to combat cancer cells and is approved for stage IV non-small cell lung cancer (NSCLC) patients with over 50% PD-L1 expression on tumor surfaces. However, uncertainty remains regarding whether immunotherapy alone or in combination with chemotherapy yields better results. Although both treatment strategies are approved, head-to-head evidence comparing these approaches is lacking. Large trials indicate that women derive less benefit from immunotherapy alone compared to men, while benefiting more from a combination therapy. However, women are often still treated with immunotherapy alone due to a lack of prospective clinical trial evidence supporting combined treatment\'s superiority. This world\'s first gender-specific trial aims to determine whether combined treatment is better than immunotherapy alone for female patients. All patients will be randomly assigned to one of the two treatment strategies, with the primary endpoint being the time until disease progression. Additional analyses will evaluate survival and quality of life differences. This investigator-initiated trial, has the potential to reshape clinical practice and improve outcomes for women with lung cancer worldwide.