The SWOG S2302 Pragmatica-Lung trial is making waves in the medical field with its innovative design and approach. This groundbreaking trial aimed to test a new combination treatment for stage 4 or recurrent non-small cell lung cancer (NSCLC) that had been previously treated with immunotherapy and chemotherapy.
The trial compared the investigational combination of ramucirumab (Cyramza) and pembrolizumab (Keytruda) to standard treatments, with the primary objective of evaluating overall survival. The results, which will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, show that the investigational combination did not significantly extend overall survival compared to standard treatments.
Despite the negative outcome in terms of survival benefit, the Pragmatica-Lung trial has been a success in other ways. The trial’s rapid development and implementation, coupled with its broad and representative patient enrollment, demonstrate a new model for large randomized studies. This model emphasizes inclusivity, efficiency, and reduced burden for both clinical staff and participants.
A second interim analysis of the trial data in April confirmed that the investigational combination did not improve overall survival compared to standard care. However, no safety concerns were identified, and patients who were benefiting from the treatment could continue with the protocol.
The trial enrolled a diverse group of patients, with strong representation from demographic groups that are often underrepresented in clinical trials. This broad representation ensures that the trial results are generalizable across the U.S. population.
The swift enrollment and reduced data collection burden of the Pragmatica-Lung trial allowed for a quick turnaround in answering the primary research question. The trial’s design was also notable for its efficiency, completing protocol development in a fraction of the time typically required for such studies.
Overall, the Pragmatica-Lung trial sets a new standard for large pragmatic trials in oncology. Its innovative design and approach pave the way for future studies to be more inclusive, efficient, and impactful. The results of this trial will have far-reaching implications for the design and conduct of clinical trials in the future.
