The unique public-private partnership that undergirded the Lung-MAP trial for almost a decade may serve as a model for future clinical research that is more rapid, innovative, and inclusive, according to a recent report published by Herbst et al in Clinical Cancer Research.
Background
The Lung-MAP trial was the first National Cancer Institute (NCI)-sponsored precision medicine clinical trial in lung cancer.
“[The] Lung-MAP [trial] is a unique public-private partnership that has increased the access to new treatment options for patients with lung cancer across the country, including patients in rural communities and from diverse populations. It’s important that we now replicate the success of Lung-MAP in other cancer types so we can quickly move innovative science into clinical trials and benefit our patients,” emphasized lead report author Roy S. Herbst, MD, PhD, the Ensign Professor of Medicine and Assistant Dean for Translational Research at the Yale School of Medicine, Deputy Director of the Yale Cancer Center, Chief of Medical Oncology at the Yale Cancer Center and Smilow Cancer Hospital, and a co–senior study author of the Lung-MAP trial.
Findings From the New Report
In the new report, investigators detailed the lessons they learned from the public-private partnership of the Lung-MAP trial.
Starting in 2012, a broad collaboration of experts and stakeholders from academia, government, industry, and patient advocacy developed the protocol as a sustainable infrastructure for testing precision medicine advances in treating non–small cell lung cancer (NSCLC). The collaboration now includes the NCI, SWOG Cancer Research Network, Friends of Cancer Research, the Foundation for the National Institutes of Health (NIH), Foundation Medicine, pharmaceutical companies that provide drugs for analysis, several lung cancer advocacy organizations, and the other NCI National Clinical Trials Network groups that assess adult patients with cancer.
They noted that the Lung-MAP trial—and the partnership that spawned it—grew out of a need for new clinical trial models that would rapidly and efficiently test novel therapies targeting the specific molecular and genomic characteristics of each patient’s tumor.
The investigators identified key attributes that have made the Lung-MAP master protocol partnership successful. Among them were:
- Ensure the trial evolves as the treatment and drug development landscape evolves through close collaboration not only between researchers and drug companies but also between multiple drug companies.
- Align potentially conflicting organizational cultures to maximize efficiencies and share project leadership.
- Maintain a pipeline of new drug candidates based on a rigorous and continuous vetting process.
- Use genomic sequencing data and substudy biospecimens to identify new drug targets and explore factors affecting disease response and treatment resistance.
- Promote further innovation in clinical research using the strengths of the partnership—for instance, a positive Lung-MAP substudy led to a phase III confirmation study that is now the first pilot under the U.S. Food and Drug Administration’s Project Pragmatica.
- Utilize a precision medicine master protocol to bring cutting-edge advances to a larger group of community-based treatment centers as well as allow for broader patient access and clinical trials that are more inclusive than standard industry-run trials.
Conclusions
The investigators underscored that the Lung-MAP trial’s public-private partnership may have been critical to enrolling a more representative group of patients than traditional trials and may be a way forward for diversifying future industry trials.
“[The] Lung-MAP [trial] brought together academia, advocacy, federal agencies, and industry with a shared goal of bringing new advances in cancer treatment to all patients as quickly and safely as possible. I am proud of the achievements we’ve made together over the last decade and look forward to helping others model programs based on [the] Lung-MAP [trial’s] success,” Dr. Herbst concluded.
Disclosure: The Lung-MAP trial was funded by grants from the NCI/NIH and in part by AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Genentech, and Pfizer through the Foundation for the NIH in partnership with Friends of Cancer Research. For full disclosures of the study authors, visit aacrjournals.org.
