Dec. 18, 2015 -
Trial design is hard. It's especially hard now, when new oncology drugs are seemingly approved every 10 minutes. The standard of care in many malignancies is turning over so quickly, it's nearly impossible to keep up. In that spirit, I am still happy to tell you, however, today's a big day. After months of work, we activate a major revision to Lung-MAP, our historic lung cancer precision medicine trial.
Immunotherapy in advanced squamous cell lung cancer came of age early in this trial. But our study PI's reacted quickly and modified the trial, with nice support from our partners, including the NCI. Reacting mostly to FDA approval of nivolumab, the S1400 trial will now offer a new nivolumab versus nivolumab+ipilimumab sub-study. The revised design also turns three biomarker-driven sub-studies into single arm Phase II trials testing targeted treatments for advanced squamous cell lung cancer, aiming to find early signals of efficacy.
Prior docetaxel use is no longer an exclusion criteria, which will allow many more patients to enroll. And patients can now pre-screen for the trial during any line of their treatment. That means that if first-line therapy fails -- as it unfortunately does in most cases -- patients have an immediate treatment "Plan B."
Word about these changes, along with others such as new model consent forms, went out today to more than 650 active Lung-MAP sites from California to Connecticut. The news heralds a continuing bright future for Lung-MAP. It's special. With its cutting-edge "master protocol" design, Lung-MAP gives us significant bang for our buck, offering four trials in one and offering a large percentage of advanced squamous patients a study treatment option. Lung-MAP also brings together 10 public and private partners, making it the most comprehensive and collaborative lung cancer trial active in the U.S.
Making epic changes to a landmark trial takes teamwork. I'd like to thank the Lung-MAP team for the thousands of hours of work they put in this year:
- Drs. Vali Papadimitrakopoulou, Roy Herbst, Fred Hirsch, Philip Mack, and David Gandara for their scientific and medical leadership, and for championing this trial with their peers throughout the NCTN and across the U.S.
- Dana Sparks, Crystal Miwa, and the protocol team in our SWOG operations office, for doing the heaviest lifting on the revision. This victory is theirs!
- Drs. Mike LeBlanc, Mary Redman and the team in SWOG's Statistical Center for the brilliant umbrella design, and their relentless pursuit to improve it.
- Nathan Eriksen, SWOG's chief of administration, for mastering multiple budgets with precision and patience.
- Evonne Lackey, Karen Anderson and the crew at Cancer Research And Biostatistics (CRAB), who deftly juggle trial data and aid in accrual.
- Drs. Jeff Abrams, Holly Massett and their team at the NCI for generously marshaling their many resources -- time, talent, vision and, yes, money -- to ensure Lung-MAP's success.
- Ellen Sigal and Ryan Hohman of Friends of Cancer Research for keeping us focused on what counts -- quickly getting treatments to patients who need them most.
- David Wholley and Ron Benjamin at the Foundation for the National Institutes of Health for managing so many important contracts with our pharmaceutical partners and helping with overall organization, conduct, and budgeting.
So, readers, please help me congratulate the S1400 team on their good work. They're searching for cures for our biggest cancer killer. And despite all the rapid changes, they're keeping us in the race.