Lung Master Protocol (Lung-MAP) - A biomarker-driven protocol for accelerating development of therapies for squamous cell lung cancer: SWOG S1400

Clinical Cancer Research

Volumn 21, Issue 7, 2015, Pages 1514-1524

  Herbst, Roy S ^a   Gandara, David R ^b   Hirsch, Fred R ^c   Redman, Mary W ^d   LeBlanc, Michael ^d   Mack, Philip C ^b   Schwartz, Lawrence H ^e   Vokes, Everett ^f   Ramalingam, Suresh S ^g   Bradley, Jeffrey D ^h   Sparks, Dana ⁱ   Zhou, Yang ^a   Miwa, Crystal ⁱ   Miller, Vincent A ^j   Yelensky, Roman ^j   Li, Yali ^j   Allen, Jeff D ^k   Sigal, Ellen V ^k   Wholley, David ^l   Sigman, Caroline C ^m   Blumenthal, Gideon M ⁿ   Malik, Shakun ^o   Kelloff, Gary J ^o   Abrams, Jeffrey S ^o   Blanke, Charles D ^p   Papadimitrakopoulou, Vassiliki A ^q   more..

^a YALE CANCER CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^d Fred Hutchinson Cancer Research Center   (United States)

^e Och Spine at New York Presbyterian Hospitals   (United States)

^f UNIVERSITY OF CHICAGO   (United States)

^g EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ SWOG Operations   (United States)

^j FOUNDATION MEDICINE   (United States)

^k Friends of Cancer Research   (United States)

^l NATIONAL INSTITUTES OF HEALTH   (United States)

^m CCS Associates   (United States)

ⁿ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^o NATIONAL CANCER INSTITUTE   (United States)

^p OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^q UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AZD 4547; DURVALUMAB; PALBOCICLIB; RILOTUMUMAB; TASELISIB; ANTINEOPLASTIC AGENT; TUMOR MARKER;

ARTICLE; DRUG DESIGN; DRUG INDUSTRY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; FRIEND; HEALTH CARE ORGANIZATION; HUMAN; INTERNATIONAL COOPERATION; LUNG MASTER PROTOCOL; MONOTHERAPY; NEXT GENERATION SEQUENCING; ORGANIZATION; PRIORITY JOURNAL; PROTEIN ANALYSIS; PUBLIC-PRIVATE PARTNERSHIP; SQUAMOUS CELL LUNG CARCINOMA; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; CLINICAL TRIAL; CONTROLLED STUDY; GENETICS; LUNG NEOPLASMS; METHODOLOGY; PERSONALIZED MEDICINE; PHASE 2 CLINICAL TRIAL; PROCEDURES; RANDOMIZED CONTROLLED TRIAL;

ANTINEOPLASTIC AGENTS; BIOMARKERS, TUMOR; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; HUMANS; LUNG NEOPLASMS; PRECISION MEDICINE; RESEARCH DESIGN;

EID: 84927606243     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-3473     Document Type: Article

References (43)

1. Collisson EA, Campbell JD, Brooks AN, Berger AH, Lee W, Chmielecki J, et al. Comprehensive molecular profiling of lung adenocarcinoma. Nature 2014;511:543-50.
2. Hammerman PS, Lawrence MS, Voet D, Jing R, Cibulskis K, Sivachenko A, et al. Comprehensive genomic characterization of squamous cell lung cancers. Nature 2012;489:519-25.
3. Hirsch FR, Janne PA, Eberhardt WE, Cappuzzo F, Thatcher N, Pirker R, et al. Epidermal growth factor receptor inhibition in lung cancer: status 2012. J Thorac Oncol 2013;8:373-84.
4. Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, et al. Anaplastic lymphoma kinase inhibition in non-small cell lung cancer. N Engl J Med 2010;363:1693-703.
5. Shaw AT, Engelman JA. Ceritinib in ALK-rearranged non-small cell lung cancer. N Engl J Med 2014;370:2537-9.
6. McKeage K. Alectinib: a review of its use in advanced ALK-rearranged non-small cell lung cancer. Drugs 2015;75:75-82.
7. Kodama T, Tsukaguchi T, Satoh Y, Yoshida M, Watanabe Y, Kondoh O, et al. Alectinib shows potent antitumor activity against RET-rearranged non- small cell lung cancer. Mol Cancer Ther 2014;13:2910-8.
8. Cardarella S, Johnson BE. The impact of genomic changes on treatment of lung cancer. Am J Respir Crit Care Med 2013;188:770-5.
9. Soria JC, Mok TS, Cappuzzo F, Janne PA. EGFR-mutated oncogeneaddicted non-small cell lung cancer: current trends and future prospects. Cancer Treat Rev 2012;38:416-30.
10. Langer CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, et al. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small cell lung cancer. J Clin Oncol 2014;32:2059-66.
11. Dilts DM. Time has come to raise the bar in oncology clinical trials. J Clin Oncol 2014;32:1186-7.
12. Ellis LM, Bernstein DS, Voest EE, Berlin JD, Sargent D, Cortazar P, et al. American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol 2014;32:1277-80.
13. 21st Century Cures: Modernizing Clinical Trials: Hearing before the Subcommittee on Health of the House Committee on Energy and Commerce, United States House of Representatives, 113th Cong., 2nd Sess., July 9, 2014.
14. Sleijfer S, Bogaerts J, Siu LL. Designing transformative clinical trials in the cancer genome era. J Clin Oncol 2013;31:1834-41.
15. Conley BA, Doroshow JH. Molecular analysis for therapy choice: NCI MATCH. Semin Oncol 2014;41:297-9.
16. Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ. ISPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharm Ther 2009;86:97-100.
17. Kaplan R, Maughan T, Crook A, Fisher D, Wilson R, Brown L, et al. Evaluating many treatments and biomarkers in oncology: a new design. J Clin Oncol 2013;31:4562-8.
18. Kim ES, Herbst RS, Wistuba II, Lee JJ, Blumenschein GR Jr, Tsao A, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov 2011;1:44-53.
19. Papadimitrakopoulou V, Wistuba II, Lee JJ, Tsao AS, Kalhor N, Fossella FV, et al. BATTLE-2 program: a biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC). J Clin Oncol, 2013 (suppl; abstr TPS8118).
20. Park JW, Liu MC, Yee D, DeMichele A, van't Veer L, Hylton N, et al. Neratinib plus standard neoadjuvant therapy for high-risk breast cancer: efficacy results from the I-SPY 2 TRIAL [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; 2014. Abstract nr CT227.
21. Positive Results for Drug Combo in I-SPY 2 Trial. Cancer Discov 2014;4: OF2.
22. Herbst R, Rubin E, LaVange L, Abrams J, Wholley D, Arscott K, et al. Design of a disease-specifi c master protocol [abstract on the Internet]. Issue brief: conference on Clinical Cancer Research, November 2012. Washington: Friends of Cancer Research; 2012 [updated. 2012; cited 2014 August 27]; Available from: http://www.focr.org/sites/default/ files/CCCR12Master- Protocol.pdf.
23. Lewis DR, Check DP, Caporaso NE, Travis WD, Devesa SS. US lung cancer trends by histologic type. Cancer 2014;120:2883-92.
24. Rooney M, Devarakonda S, Govindan R. Genomics of squamous cell lung cancer. Oncologist 2013;18:707-16.
25. Travis WD. Pathology of lung cancer. Clin Chest Med 2011;32:669-92.
26. Drilon A, Rekhtman N, Ladanyi M, Paik P. Squamous-cell carcinomas of the lung: emerging biology, controversies, and the promise of targeted therapy. Lancet Oncol 2012;13:e418-26.
27. Hotta K, Suzuki E, Di Maio M, Chiodini P, Fujiwara Y, Takigawa N, et al. Progression-free survival and overall survival in phase III trials of molec-ular- targeted agents in advanced non-small-cell lung cancer. Lung Cancer 2013;79:20-6.
28. Frampton GM, Fichtenholtz A, Otto GA, Wang K, Downing SR, He J, et al. Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing. Nat Biotechnol 2013;31: 1023-31.
29. Collins FS. Genome-sequencing anniversary. Faces of the genome. Science 2011;331:546.
30. Lopez S, Schwab CL, Cocco E, Bellone S, Bonazzoli E, English DP, et al. Taselisib, a selective inhibitor of PIK3CA, is highly effective on PIK3CA-mutated and HER2/neu amplified uterine serous carcinoma in vitro and in vivo. Gynecol Oncol 2014;135:312-7.
31. Ndubaku CO, Heffron TP, Staben ST, Baumgardner M, Blaquiere N, Bradley E, et al. Discovery of 2-{3-[2-(1-isopropyl-3-methyl-1H-1,2-4- triazol-5-yl)-5,6-dihydrobenzo[f]imidazo[1,2-d][1,4]oxazepin-9-yl]-1H-pyrazol- 1-yl}-2-methylpropanamide (GDC-0032): a beta-sparing phosphoinositide 3-kinase inhibitor with high unbound exposure and robust in vivo antitumor activity. J Med Chem 2013;56:4597-610.
32. Hosford SR, Miller TW. Clinical potential of novel therapeutic targets in breast cancer: CDK4/6, Src, JAK/STAT, PARP, HDAC, and PI3K/AKT/mTOR pathways. Pharmacogenomics Pers Med 2014;7:203-15.
33. Cadoo KA, Gucalp A, Traina TA. Palbociclib: an evidence-based review of its potential in the treatment of breast cancer. Breast Cancer 2014;6: 123-33.
34. Rocca A, Farolfi A, Bravaccini S, Schirone A, Amadori D. Palbociclib (PD 0332991): targeting the cell cycle machinery in breast cancer. Expert Opin Pharmacother 2014;15:407-20.
35. Gavine PR, Mooney L, Kilgour E, Thomas AP, Al-Kadhimi K, Beck S, et al. AZD4547: an orally bioavailable, potent, and selective inhibitor of the fibroblast growth factor receptor tyrosine kinase family. Cancer Res 2012;72:2045-56.
36. Zhang J, Zhang L, Su X, Li M, Xie L, Malchers F, et al. Translating the therapeutic potential of AZD4547 in FGFR1-amplified non-small cell lung cancer through the use of patient-derived tumor xenograft models. Clin Cancer Res 2012;18:6658-67.
37. Gordon MS, Sweeney CS, Mendelson DS, Eckhardt SG, Anderson A, Beaupre DM, et al. Safety, pharmacokinetics, and pharmacodynamics of AMG 102, a fully human hepatocyte growth factor-neutralizing monoclonal antibody, in a first-in-human study of patients with advanced solid tumors. Clin Cancer Res 2010;16:699-710.
38. Rilotumumab extends PFS in gastric cancer. Cancer Discov 2014;4:OF1.
39. Johnson DB, Rioth MJ, Horn L. Immune checkpoint inhibitors in NSCLC. Curr Treat Options Oncol 2014;15:658-69.
40. Lu J, Lee-Gabel L, NadeauMC, Ferencz TM, Soefje SA. Clinical evaluation of compounds targeting PD-1/PD-L1 pathway for cancer immunotherapy. J Oncol Pharm Pract 2014 June 9. [Epub ahead of print].
41. Cerami E, Gao J, Dogrusoz U, Gross BE, Sumer SO, Aksoy BA, et al. The cBio cancer genomics portal: an open platform for exploring multidimensional cancer genomics data. Cancer Discov 2012;2:401-4.
42. Gao J, Aksoy BA, Dogrusoz U, Dresdner G, Gross B, Sumer SO, et al. Integrative analysis of complex cancer genomics and clinical pro files using the cBioPortal. Sci Signal 2013;6:pl1.
43. Mermel CH, Schumacher SE, Hill B, Meyerson ML, Beroukhim R, Getz G. GISTIC2.0 facilitates sensitive and confident localization of the targets of focal somatic copy-number alteration in human cancers. Genome Biol 2011;12:R41.