Format

Send to

Choose Destination
Chin Clin Oncol. 2015 Sep;4(3):36. doi: 10.3978/j.issn.2304-3865.2015.09.02.

Lung-MAP--framework, overview, and design principles.

Author information

1
Department of Thoracic and Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center, USA.
2
Clinical Statistics, Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.
3
University of California Davis Cancer Center, Sacramento, CA, USA.
4
Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA.
5
Department of Thoracic and Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center, USA. vpapadim@mdanderson.org.

Abstract

Metastatic lung squamous cell carcinoma (SCC) is a common disease with limited therapeutic options and poor patient outcomes. Standard "all comers" clinical trial designs usually benefit only a small population sub-group. Targeted-therapy matched clinical trials have a higher potential to achieve better results, however, given the low frequency of driver genetic alterations, they are associated with a large number of screen-failures, are not cost-effective, and frequently not feasible. Lung-MAP is an umbrella master protocol for recurrent or metastatic lung SCC patients that uses a central genomic profiling screening platform to allocate patients to phase II/III biomarker-matched target therapy clinical trials or to a "non-match" treatment arm; therefore, all eligible patients screened can be treated under the protocol. If evidence of efficacy is seen in the phase II trial portion for a particular treatment/marker combination, that sub-study moves directly to phase III and incorporates the patients treated in phase II. Lung-MAP has an efficient and adaptable structure that allows for sub-studies to open and close based on changes in an evolving cancer research field. It also provides a path for FDA-approval in order to bring promising agents to clinic in a time efficient manner, with the ultimate goal of significantly improving lung SCC patient's quality and length of life.

KEYWORDS:

Clinical trial; lung cancer; master protocol; squamous cell carcinoma (SCC)

[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for AME Publishing Company
Loading ...
Support Center