Lung-MAP: Master Protocol for Treatment of Non-Small Cell Lung Cancer

Lung-MAP: Master Protocol for Treatment of Non-Small Cell Lung Cancer (Lung-MAP) is a groundbreaking multi-center clinical trial that uses a multi-sub-study, targeted screening approach to match patients with sub-studies testing investigational new treatments based on their unique tumor profiles. Lung-MAP uses cutting-edge genomic profiling or type of cancer trait (biomarker) to match patients to sub-studies testing new investigational therapies that may target the genomic alterations, or mutations, found to be driving the growth of their cancer. Instead of having to undergo multiple diagnostic tests to determine eligibility for many different studies, enrollees are tested for genomic alterations just once according to a master protocol and ‘matched’ to a sub-study on the basis of this single screen. In addition, the protocol also includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will is currently a randomized non-match study of two cutting-edge immunotherapies.

For more information please see the Lung-MAP website: lung-map.org

Results & Accomplishments

As of September 24, 2018, 1791 patients have been registered to Lung-MAP; of these, a total of 1362 have been assigned to sub-studies. At this time, 7 sub-studies have been completed and data is being presented at national and international meetings. The trial still has 2 active sub-studies and anticipates another 2-4 studies opening within the next 6 months. In November 2018, the trial will be expanded to all NSCLC histologies, IO combinations for anti-PDL-1 refractory patients, and inclusion of ctDNA liquid biopsy screening

Scientific Publications

Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400. Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, Schwartz LH, Vokes E, Ramalingam SS, Bradley JD, Sparks D, Zhou Y, Miwa C, Miller VA, Yelensky R, Li Y, Allen JD, Sigal EV, Wholley D, Sigman CC, Blumenthal GM, Malik S, Kelloff GJ, Abrams JS, Blanke CD, Papadimitrakopoulou VA. Clin Cancer Res. 2015 Apr 1;21(7):1514-24. Epub 2015 Feb 13.

Lung-MAP--framework, overview, and design principles. Ferrarotto R, Redman MW, Gandara DR, Herbst RS, Papadimitrakopoulou VA. Chin Clin Oncol. 2015 Sep;4(3):36.

Innovative Clinical Trials: The LUNG-MAP Study. Steuer CE, Papadimitrakopoulou V, Herbst RS, Redman MW, Hirsch FR, Mack PC, Ramalingam SS, Gandara DR. 2015 May;97(5):488-91.

The Master Protocol Concept. Redman MW, Allegra CJ. 2015 Oct;42(5):724-30. Epub 2015 Jul 10.

The promise of lung master protocol for squamous cell carcinoma: one trial to rule them all, one trial to find them…? Wright GM, Russell PA. Ann Transl Med. 2015 Sep;3(15):219.

Improving Clinical Trial Efficiency: Thinking outside the Box. Mandrekar SJ, Dahlberg SE, Simon R. Am Soc Clin Oncol Educ Book. 2015:e141-7.

Squamous cell lung cancer: from tumor genomics to cancer therapeutics. Gandara DR, Hammerman PS, Sos ML, Lara PN Jr, Hirsch FR. Clin Cancer Res. 2015 May 15;21(10):2236-43.

Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer. Malik S, Pazdur R, Abrams J, Socinski M, Sause WT, Harpole D, Welch J, Korn E, Ullmann C, Hirsch F. Journal of Thoracic Oncology 9(10):1443-1448, 2014. 

EGFR tyrosine kinase inhibitors in squamous cell lung cancer. Hirsch F, Herbst R, Gandara D. Aug;16(8):872-873, 2015. 

Lung cancer in the era of precision medicine. Politi K, Herbst R. Clinical Cancer Research May 15;21(10):2213-2220, 2015. 

Overview of thoracic oncology trials in cooperative groups around the globe. Salahudeen A, Patel MI, Baas P, Curran W, Bradley JD, Gandara D, Goss P, Mok T, Ramalingam SS, Vokes EE, Malik S, Wakelee H. Clinical Lung Cancer 2016 Jun 27 [Epub ahead of print], 2016. 

Selected Abstracts

Lung master protocol in squamous cell lung Cancer (Lung-MAP, S1400). Gandara D, Redman M, Herbst R, Abrams J, Malik S, Sigal E, Hirsch F, Mack P, Papadimitrakopoulou V. Journal of Thoracic Oncology 10(9):(Suppl 2, abst ED07.03), 2015. 

Patients, investigators and pharmaceuticals working together to accelerate research and access: the lung cancer master protocol (Lung-MAP) clinical trial. Papadimitrakopoulou V, Gandara D, Redman M, Hirsch F, Mack P, Borghaei H, Langer C, Engelman J, Edelman M, Albain K, Lara P, Aggarwal C, Socinski M, Sigal E, Herbst R. Journal of Thoracic Oncology 10(9):S141 (Suppl 2, MTE 02), 2015. 

Integrating traditional Electronic Data Capture (EDC) with new systems. Cook C, Phillips T, Leblanc M. Society for Clinical Trials (abstract not available), 2016.

Lung-MAP (S1400) Lung Master Protocol: Accrual and Genomic screening updates. Papadimitrakopoulou V, Redman M, Gandara D, Hirsch F, Mack P, Borghaei H, Langer C, Wade J, Edelman M, Albain K, Lara P, Aggarwal C, Socinski M, Gettinger S, Bazhenova L, Malik S, Miller V, McDonough S, Sigal E, Kelly K, Herbst R. World Conference on Lung Cancer, 2016. 

Lung-MAP (S1400) Lung Cancer Master Protocol: Accrual, demographics, and molecular markers. Papadimitrakopoulou V, Redman M, Gandara D, Hirsch F, Mack P, Gorghaei H, Langer C, Engelman J, Edelman M, Albain K, Lara P, Aggarwal C, Socinski M, Gettinger S, Bazhenova L, Malik S, McDonough S, Sigal E, Kelly K, Herbst R. Journal of Clinical Oncology 34, 2016 (suppl; abstr 9088), 2016. 

A phase II study of Durvalumab (MEDI4736) for previously treated patients with stage IV squamous NSCLC (SqNSCLC): Lung-MAP Sub-study SWOG S1400A. Papadimitrakopoulou V, Redman M, Borghaei H, Wagar SN, Robert F, Kiefer GJ, McDonough S, Herbst R, Kelly K, Gandara D. European Lung Cancer Conference, 2017.

A phase II study of gdc-0032 (taselisib) for previously treated PI3K positive patients with stage IV squamous cell lung cancer (sqNSCLC): lung-map sub-study SWOG S1400B. Wade JL, Redman M, Langer C, Aggarwal C, Bradley JD, Crawford J, Miao J, Griffin K, Herbst R, Kelly K, Gandara D. American Society of Clinical Oncology Annual Meeting, poster session, 2017.

A phase II study of palbociclib (p) for previously treated cell cycle gene alteration positive patients (pts) with stage IV squamous cell lung cancer (scc): lung-map sub-study SWOG S1400C. Edelman M, Redman M, Albain KS, McGary E, Rafique N, Petro D, Wagar S, Griffin K, Miao J, Papadimitrakopoulou V, Kelly K, Gandara D, Herbst R. American Society of Clinical Oncology Annual Meeting, poster session, 2017.

Phase II study of the FGFR inhibitor AZD4547 in previously treated patients with FGFR pathway-activated stage IV squamous cell lung cancer (sqNSCLC): lung-map sub-study SWOG S1400D. Aggarwal C, Redman M, Lara P, Borghaei H, Hoffman P, Bradley JD, Griffin K, Miao J, Mack PC, Papadimitrakopoulou V, Herbst R, Kelly K, Gandara D. American Society of Clinical Oncology Annual Meeting, poster session, 2017.

Media

Targeted Oncology (August 21, 2019): Precision Medicine Trials and Molecular Testing Guidelines Expand to Reach More Patients

FNIH Press Release (January 29, 2019): Lung-MAP Precision Medicine Trial Expands To Include More Patients

Refer to the Lung-MAP website: lung-map.org/news-media/archive/press

Partners

Managing Partners include:

Public-Sector Partners:

Foundation for the National Institutes of Health
Friends of Cancer Research
National Cancer Institute – National Clinical Trials Network
SWOG Cancer Research Network

Private-Sector Partners:
Amgen, Inc.*
AbbVie, Inc.*
AstraZeneca Pharmaceuticals LP*
Bristol Myers-Squibb Company*
Genentech, a member of the Roche group*
Medimmune*
Pfizer, Inc.*

*Provides financial or in-kind support for this program.

For a full list, visit: lung-map.org/about/partners

Contacts

Amrin Chowdhury, MS, Project Manager, Cancer achowdhury@fnih.org

Stacey J. Adam, Ph.D., Director, Cancer - Research Partnerships sadam@fnih.org;