Pragmatica: Lung cancer trial tests streamlined design, inclusive eligibility
The National Cancer Institute (NCI) is sponsoring a clinical trial in advanced non-small cell lung cancer (NSCLC) that will test the use of a streamlined trial design with limited endpoints, inclusive eligibility criteria and minimal data reporting requirements.The trial is part of a larger effort by the NCI, part of the National Institutes of Health (NIH), and the US Food and Drug Administration (FDA) to create simplified clinical trials to assess cancer treatments that focus on collecting only the data that is necessary, rather than collecting data because it has been done historically. “Every piece of data costs money to collect. It takes time,” said James Doroshow, director of the NCI’s Division of Cancer Treatment and Diagnosis. “This [trial] is a great example of how one can do an important study and collect a lot less information and still, we believe, yield an important outcome.” (RELATED: Califf and Pazdur talk return to office, accelerated approvals and Project Pragmatica, Regulatory Focus 18 November 2022)
The Pragmatica-Lung Study, or S2302 (NCT05633602), is a randomized, phase 3 trial evaluating the combination of Cyramza (ramucirumab) and Keytruda (pembrolizumab) compared to standard of care treatment in patients with advanced NSCLC who have progressed after prior treatment with immunotherapy and chemotherapy. The Southwest Oncology Group (SWOG) Cancer Research Network designed the study and is leading the trial in collaboration with the Alliance for Clinical Trials in Oncology.
“Our goals for the S2302 trial are to empower investigators to treat patients as they would be treated in their real-world practice,” Karen Reckamp, study chair for Pragmatica-Lung and director of medical oncology at Cedars-Sinai Cancer Center in Los Angeles, said during a press conference to announce the trial launch. “We want to decrease barriers to enrollment to allow more patients, and diverse patients, to enroll into the trial, and we also want to minimize the data collection burden. Trials are becoming more and more complex and the actual staff time and collection time for getting this data has also increased over time.”
The Pragmatica-Lung Study is a good candidate for a streamlined trial design because it is evaluating two already-approved treatments that have been well studied, Reckamp said. “These are medications – ramucirumab and pembrolizumab – that have been used in many tumor types for many, many years and we know the side effects; we know how they work,” she said.
The study has limited objectives and will only assess overall survival and serious and unexpected high-grade (Grade 3 or higher) treatment-related adverse events. The pragmatic study will also minimize data reporting requirements by reducing the time point data required, the number of forms required, and the number of data elements required to be reported within a form. Additionally, the study does not include tissue specimen collection, image submission form disease assessments or Patient-Reported Outcome (PRO) instruments.
Trial investigators will seek to enroll up to 700 adults with stage 4 or recurrent NSCLC who were previously treated with immune checkpoint inhibitors and chemotherapy. Enrollment is expected to be completed by the end of 2025.
The trial will allow for remote informed consent and investigators will be watching to see if that helps with patient accrual, said Jhanelle Gray, chair of the SWOG Lung Committee and chair of the department of thoracic oncology at Moffitt Cancer Center in Tampa, Florida. The SWOG Cancer Research Network will meet monthly throughout the course of the study to monitor enrollment in the study, paying special attention to the accrual of underrepresented patients, Gray said.
Merck, which manufactures Keytruda, and Eli Lilly and Co., which manufactures Cyramza, are providing the study drugs and additional trial funding.
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