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SWOG Update
Spring 2014

Contents  
Welcome to the Spring 2014 SWOG Update.

For all members and friends of SWOG, the SWOG Update will keep you informed of what's happening with the group. News to report? Send it to communications@swog.org.

View a one-page version for printing.
 
from The Front Line  
Charles D. Blanke photoSome Recent Posts from the Chair's Blog:
If you haven't kept up with them weekly, here are three you shouldn't miss: [more]

Study Updates  

LUNG-MAP logo
Lung-MAP S1400: Lung Master Protocol rolls to the launch pad What do you call five randomized studies of targeted investigational agents for squamous cell lung cancer rolled into one overarching clinical trial under a single genomic screening assay? The lung master protocol, of course, or Lung-MAP. As S1400 activation approaches, here's what you need to know to get started. [more]

Rare Cancers
S1221: Reactivating a BRAF inhibitor with an AKT inhibitor
AKT1 inhibitor complexes About 4,000 patients each year in the United States are diagnosed with metastatic melanoma that is driven, at least in part, by mutations to the BRAF gene. BRAF inhibitor therapy can help, but only for a while. S1221 investigators hypothesize that in a subset of those patients whose cancer has grown resistant to a BRAF inhibitor, adding the AKT inhibitor GSK2141795 to therapy will prompt secondary tumor responses. [more]

S0919 adds MDS-to-AML patients
Agranular myeloblasts S0919 tests whether adding pravastatin to chemo can lower remission rates for patients with relapsed acute myeloid leukemia (AML). Eligibility criteria were recently broadened, and the study population now includes patients whose AML arose from a previous Myelodysplastic Syndrome (MDS) diagnosis. [more]

S0820 PACES throws open an accrual window
PACES logo Many sites have found the registration-within-42-days-of-colonoscopy requirement for the PACES colon cancer prevention study to be a narrow time target to hit. So a revision of the protocol now gives up to six months of elbow room. [more]

 
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STUDY UPDATE

S1400: Lung-MAP, the Lung Master Protocol, coming soon

LUNG-MAP logo

Lung-MAP Launch in San Francisco

An S1400 kickoff training session will take place at the spring group meeting in San Francisco on Friday, May 2, 6:00-7:30 pm, featuring brief presentations by study chairs, statisticians, data management staff, and more. This session will fulfill the training requirement you'll need to meet before you can enroll patients to S1400; you can attend in-person or complete the module online later. You'll leave the San Francisco session with the knowledge and tools to generate excitement about launching Lung-MAP at your institution!

Lung-MAP 101 (PDF)

SWOG S1400 -- the Lung Master Protocol, or Lung-MAP -- is expected to activate this spring. Given the trial framework and the unprecedented scope of collaboration behind it, this will be a landmark study from the day it launches.

Lung-MAP is a large scale, phase II/III screening/clinical registration protocol that will genomically screen patients with advanced stage lung squamous cell cancer moving to second-line therapy, and will use the screening results to direct each patient to the most appropriate one of five (or more) sub-studies. Patients on each sub-study will be randomized to either standard of care (docetaxel or erlotinib) or biomarker-driven targeted therapy with an investigational agent.

Each Lung-MAP sub-study is designed around a genotypically defined alteration in the tumor and a drug that targets it. Each sub-study will function autonomously, will open and close independently, and will be independently powered for overall survival (OS) with an interim analysis for progression-free survival (PFS) to determine whether to proceed from Phase II into Phase III. When an endpoint for a sub-study is met, that drug-biomarker specific combination may proceed to FDA for approval review of the new drug with its matching companion diagnostic. When an endpoint is not met, that sub-study will be closed and another modular sub-study of a different agent will be initiated.

SWOG's Lung-MAP partners

  • National Cancer Institute's National Clinical Trials Network
  • Foundation for the National Institutes of Health
  • Friends of Cancer Research
  • Amgen
  • Genentech
  • Pfizer
  • AstraZeneca
  • MedImmune
  • Foundation Medicine
  • multiple lung cancer advocacy organizations

Patients with tumors that do not match a drug-biomarker combination will be assigned to a "non-match" sub-study and randomized to either treatment with a designated "non-match" drug (initially an immunotherapy agent targeting PD-L1) or standard of care.

Central genomic screening testing will be performed on archival fresh frozen paraffin-embedded (FFPE) tumor to establish biomarker status within 10-14 days of screening. S1400's five sub-studies are designed to accrue a total of 400-800 patients (from 500-1,000 screened) per year over at least two years.

Lung-MAP is the result of an unprecedented public-private collaboration between government, non-profit, and for-profit organizations. If this Master Protocol strategy is successful, it could serve as a prototype for drug registration in other settings.

An S1400 kickoff training session will take place at the spring group meeting in San Francisco on Friday, May 2, 6:00-7:30 pm, featuring brief presentations by study chairs, statisticians, data management staff, and more. You'll leave the session with the knowledge and tools to generate excitement about launching Lung-MAP at your institution.


Got news to tell? Send it to communications@swog.org.