ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer
NCT ID: NCT00312377
Last Updated: 2016-09-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1690 participants
INTERVENTIONAL
2006-05-31
2014-03-31
Brief Summary
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This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.
All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.
In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.
Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.
Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Docetaxel monotherapy
Docetaxel
infusion
2
Vandetanib + Docetaxel
Docetaxel
infusion
Vandetanib
oral
Interventions
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Docetaxel
infusion
Vandetanib
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV)
* I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed.
Exclusion Criteria
* I do not have non small cell lung cancer (NSCLC)
* I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable.
* I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible)
* I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted.
* I have a history of uncontrolled irregular heartbeat
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Research Site
Fullerton, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Colorado Springs, Colorado, United States
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Norwalk, Connecticut, United States
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Ocala, Florida, United States
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Marietta, Georgia, United States
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Joliet, Illinois, United States
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Park Ridge, Illinois, United States
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Hutchinson, Kansas, United States
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Louisville, Kentucky, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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Albany, New York, United States
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Armonk, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Hickory, North Carolina, United States
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Portland, Oregon, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Ogden, Utah, United States
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Alexandria, Virginia, United States
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Salem, Virginia, United States
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Vancouver, Washington, United States
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Bahía Blanca, , Argentina
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Capital Federal, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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Graz, , Austria
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Grimmenstein, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Wels, , Austria
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Brussels (Jette), , Belgium
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Brussels (Woluwé-St-Lambert), , Belgium
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Edegem, , Belgium
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Genk, , Belgium
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Liège, , Belgium
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Fortaleza, , Brazil
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Goiânia, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Moncton, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Québec, Quebec, Canada
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Beijing, , China
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Chongqing, , China
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Guangzhou, , China
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Nanjing, , China
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Shanghai, , China
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Wuhan, , China
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Herlev, , Denmark
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København Ø, , Denmark
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Odense, , Denmark
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Roskilde, , Denmark
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Vejle, , Denmark
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Caen, , France
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Dijon, , France
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Nancy, , France
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Paris, , France
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Pierre-Bénite, , France
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Saint-Herblain, , France
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Bad Berka, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Essen, , Germany
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Großhansdorf, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Oldenburg, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Ahmedabad, , India
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Chennai, , India
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Hyderabad, , India
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Kolkata, , India
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New Delhi, , India
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Pune, , India
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Vellore, , India
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Jakarta Timur, , Indonesia
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Yogyakarta, , Indonesia
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Ancona, , Italy
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Avellino, , Italy
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Bologna, , Italy
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Genova, , Italy
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Mantova, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Parma, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Reggio Emilia, , Italy
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Akashi-shi, , Japan
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Fukuoka, , Japan
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Isehara-shi, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Okayama, , Japan
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Okazaki-shi, , Japan
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Osaka, , Japan
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Osakasayama-shi, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Toyonaka, , Japan
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Ube-shi, , Japan
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Utsunomiya, , Japan
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Yokohama, , Japan
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George Town, , Malaysia
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Kampung Baharu Nilai, , Malaysia
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Kubang Kerian, , Malaysia
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Durango, , Mexico
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Morelia, , Mexico
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Toluca, , Mexico
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's-Hertogenbosch, , Netherlands
Research Site
Amsterdam, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Coimbra, , Portugal
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Funchal, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Singapore, , Singapore
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Seoul, , South Korea
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A Coruña, , Spain
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Alicante, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Zaragoza, , Spain
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Chiang Mai, , Thailand
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
Research Site
Izmir, , Turkey (Türkiye)
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.
Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.
Heymach JV, Lockwood SJ, Herbst RS, Johnson BE, Ryan AJ. EGFR biomarkers predict benefit from vandetanib in combination with docetaxel in a randomized phase III study of second-line treatment of patients with advanced non-small cell lung cancer. Ann Oncol. 2014 Oct;25(10):1941-1948. doi: 10.1093/annonc/mdu269. Epub 2014 Jul 23.
Herbst RS, Sun Y, Eberhardt WE, Germonpre P, Saijo N, Zhou C, Wang J, Li L, Kabbinavar F, Ichinose Y, Qin S, Zhang L, Biesma B, Heymach JV, Langmuir P, Kennedy SJ, Tada H, Johnson BE. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2010 Jul;11(7):619-26. doi: 10.1016/S1470-2045(10)70132-7.
Related Links
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Other Identifiers
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6474IL/0032
Identifier Type: -
Identifier Source: secondary_id
2005-004749-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4200C00032
Identifier Type: -
Identifier Source: org_study_id
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