Creating Precision External Control Groups to Study Advanced or Metastatic Non-Small Cell Lung Cancer Treatments

What this Trial Is About

Researchers are conducting an observational study to create precision external control groups using current and future data from patients with advanced or metastatic non-small cell lung cancer NSCLC. This study aims to evaluate different patient cohorts based on specific genetic mutations, PD-L1 status, and lines of therapy to better understand outcomes in this population. Participants are grouped into various cohorts depending on their treatment stage and genetic profile, including those starting first line therapy with immune checkpoint inhibitors ICI, patients with actionable EGFR or KRAS mutations, and those receiving second or later line therapies. The study collects information on patients receiving treatments such as ICI alone or in combination with chemotherapy, targeted therapies like osimertinib, and other physician-chosen regimens. During the study, participants medical data and treatment responses will be observed without intervention. Researchers will assess objective response rates, progression-free survival, overall survival, and time to next treatment across cohorts from September 2025 to April 2029. Participants will be followed over time to gather this information, with no additional treatments or procedures mandated by the study.

An External Control Arm Study in Non-Small Cell Lung Cancer