Summer 2025 Newsletter
Oncology Practice Management — Redesigning Access: S2302 Pragmatica-Lung Study as a Model for Inclusive Cancer Trials
Meg Barbor, MPH The phase 3 S2302 Pragmatica-Lung study offers a new blueprint for cancer clinical trials, one that emphasizes simplification, inclusivity, and real-world applicability, according to Konstantin Dragnev, MD, of Dartmouth Cancer Center. By minimizing protocol requirements and simplifying enrollment, the study reduces complex barriers that have historically limited clinical trial participation. This…
Regulatory Focus — FDA white paper encourages adoption of selective safety data collection
Joanne S. Eglovitch The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) this week released a white paper aimed at encouraging the use of selective safety data collection (SSDC). This approach is designed to simplify the data gathering process for drugs that have well-established safety profiles with the goal…
News Medical — SWOG S2302 Pragmatica-Lung study demonstrates value of streamlined clinical trials in real world settings
The SWOG S2302 Pragmatica-Lung trial, which broke new ground with its streamlined pragmatic design, unusually broad eligibility criteria, and reduced data collection, has quickly answered its primary question, finding that the investigational combination it tested did not significantly extend overall survival compared to standard of care treatments. Importantly, the phase 3 trial’s rapid development and implementation,…
Bioengineer.org — S2302 Pragmatica-Lung Emerges as a Model for Faster, Leaner, and More Representative Clinical Trials
In a groundbreaking advancement for clinical trial methodology, the SWOG S2302 Pragmatica-Lung trial has demonstrated an innovative approach to cancer research, challenging traditional norms with its pragmatic design and broad eligibility criteria. Launched to assess whether a combination of ramucirumab (Cyramza) and pembrolizumab (Keytruda) could improve overall survival in patients with stage IV or recurrent…
Spring 2025 Newsletter
The Cancer Letter — Lung-MAP trial for NSCLC expands genomic screening options for patients
Most patients who enroll in the Lung-MAP precision medicine trial in non-small cell lung cancer can now be matched to a targeted investigational treatment based on the results of their prior genomic testing, without needing to submit new tumor or blood samples. This expanded screening process will help make Lung-MAP’s targeted treatment studies more accessible…
Scienmag — Lung-MAP 3.0: Pioneering Trial Broadens Genomic Screening to Enhance Patient Enrollment
Lung-MAP: Revolutionizing Precision Medicine in Advanced Non-Small Cell Lung Cancer Precision medicine has taken a significant leap forward in the fight against advanced non-small cell lung cancer (NSCLC) with the evolution of the Lung Cancer Master Protocol (Lung-MAP). Originally launched in 2014 as one of the earliest umbrella trials, Lung-MAP has continuously adapted to emerging…
The ASCO Post — Lung-MAP 3.0: Simplifying the Process to Meet Patients’ Needs
Karen Reckamp The Lung Cancer Master Protocol (Lung-MAP) is an innovative clinical trial designed to efficiently address the unmet needs of patients with advanced non–small cell lung cancer (NSCLC) following front-line therapy. This pioneering effort was the first biomarker-driven umbrella master protocol initiated by the National Cancer Institute (NCI), the NCI’s National Clinical Trials Network…