The S2302 realistic lung test, which broke the new territory with rational realistic design, unusual wide selectivity criteria and reduced data collection, quickly responded to its main question, finding that the research combination was not tested by the research combination.
It is important that the rapid development and implementation of Phase 3, coupled with the successful registration of a group of patients who widely represents the largest US population, establishes the realistic-inspiration as a model of transit for the design and conduct of future large randomized studies.
The results will be presented at the annual meeting of the US Clinical Oncology Society of 2025 in Chicago on June 2 by the co -chair of the study Konstantin Dragnev, MD, Dartmouth Cancer Center (Abstract LBA8671).
Pragmatica-Lung compared treatment with a combination of Ramucirumab (Cyramza) and Pembrolizumab (Keytruda) in the selection of a typical treatment of physician in patients with 4 or recurrent non-microcellular lungs (NSCLC). Chemotherapy. The primary objective of the study was to evaluate whether a survival benefit observed with this figure in the smaller PHASE 2 S1800A test (sub-study of the pulmonary map) would be validated in a larger, more representative population of patients.
Although the answer to the main question of the test is negative, the test itself, with its speed, its broad and extremely representative registration and the reduced load for the clinic staff and participants, was extremely positive in demonstrating the viability of a model for large, realistic, realistic and realistic clinical trials.
Karen L. Reckamp, ​​MD, MS, Cedars-Sinai Cancer Study President
A planned second temporary analysis of the Pragmatica lung data in April found that it was unlikely that the combination of research would extend overall survival compared to the care standard. Based on the analysis, the Data Monitoring and Security Committee (DSMC) recommended that the results are publicly released.
The DSMC also said that no safety concerns were identified and that patients who benefit clinically from treatment with the combination could continue the treatment of the protocol. Letter models summarizing the findings and DSMC recommendations are sent to participating clinical venues for use in the disclosure of clinical doctors and registered patients.
The April intermediate analysis found that, with 370 deaths of patients reported, overall survival was not significantly different between the arm study, with a risk ratio (HR, 95% CI) 0.99 (0.81-1.22), with p = 0.46. The average total survival was 10.1 months on the arm of the research and 9.3 months on the arm of its normal care.
Pre-defined subset analyzes evaluated the effects of treatment within the plumage cells and non-square histological subgroups. Among 29% of registered patients with slab carcinoma, HR (95% CI) was 0.82 (0.56-1.22), with P = 0.17. Between those with non-temperamental histology, HR (95% CI) was 1.09 (0.85-1.39), with p = 0.75. Long -term surveillance data is required to determine whether this difference represents a benefit for patients with tile cell histology.
“For patients who are registered in the realistic lung, overall survival appears comparable between weapons, so the research combination can provide patients with a non-chemotherapeutic regimen that is just as effective as traditional chemotherapy, but this may be less toxic,” and the Data Management Center and the Hutch Center.
The S2302 Pragmatica-Lung test is led by the Sarist Cancer Network, supported by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) and is conducted under the NCI National Network of Clinical Tests (NCI).
The study was intended to serve as a prototype for large realistic tests that would reduce the burden of participation for both clinical and patients, promoting all patients to register with the disease and could develop and be carried out more efficiently by giving us previous answers. It was developed in consultation with the US Food and Drug Administration Center (FDA) and with a collaborative influx of the division of NCI treatment and diagnosis, the defense organization Friends of Cancer Research and NCTN’s alliance for clinical trials in Oncology.
To make the test accessible to the widest possible range of patients, in as many treatment areas as possible, Pragmatica-Lung was designed with relatively few restrictions in which patients with advanced NSCLC would be eligible for registration. The event that is finally registered is very much like the US population as a whole, with strong representation of several demographic groups that often underestimate clinical trials. Of the 838 registered patients, 22 % were non -white, 13 % were black and 15 % lived in rural sites. This broad representation helps to ensure test results to be generalized throughout the US population. (See Asco Abstract 11016 for more details on the increase in representation in this test.)
With the rapid registration and the reduced weight of the data collection, the test was able to answer its main question in just more than two years, much faster than the standard phase 3 study. Opened in March 2023, completed the registration until December 2024 and informed the 2024 participants.
The test stage of the test was also unusually brief – the development of the study protocol, from the review of the original concept for activating the study, was completed in just 200 days, cutting about 100 days away from what would usually be considered an effective timetable for building a phase study of 3. It is noteworthy that this quick timetable was achieved in a study intentional study – designed so that results can be used, if necessary, in an application for review of the FDA of treatment.
“Test planning to try new treatments in settings that reflect daily practice, actual practice removes obstacles to the participation and registration of the test and completion of Jhanel, MD, Moffett Certand, Moffitt Certent, which should be applied to a test behavior that needs to be applied to. Including studies with the registration of the FDA, “Jhanelle said.
The S2302 Pragmatica-Lung study is funded through NCI/NIH grants to the Swog Cancer Cancer Network for Cancer U10CA180888 and U10CA180819 and is partially supported by Eli Lilly and Company and Merck (known as MSD outside the US and USA)
In addition to Dragnev, Redman and Reckamp, ​​co-authors at ASCO Abstract include Maya Khalil, MD, Alabama University, Birmingham. Brian S. Henick, MD, Columbia/Herbert Irving Comprehensive Cancer Center. James Moon, MS, Statistics and Data Management Center and Fred Hutch Cancer Center. Pasarlai Ahmadzai, series statistics and data management center and Fred Hutch Cancer Center. Michael LeBlanc, PhD, Series Statistics and Data Management Center and Fred Hutch Cancer Center. Daniel R. Carrizosa, MD, MS, Levine Cancer Institute/Wake Forest Baptist Comprehensive Cancer Center. Paul J. Hesketh, MD, Lahey Hospital and Medical Center. Ellen V. Sigal, PhD, Friends of Cancer Research. Jeff Allen, PhD, Friends of Cancer Research. Andreas N. Saltos, MD, Mofitt Cancer Center. Bryan A. Faller, MD, Heartland Ncorp/Missouri Baptist Medical Center. Roy S. Herbst, MD, PhD, Yale University. Charles D. Blanke, MD, Swog Network Business Center and Oregon’s University of Health and Science. and Jhanelle E. Gray, MD, Mofitt Cancer Center.
Source:
