First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia
NCT ID: NCT00322452
Last Updated: 2013-11-07
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
1329 participants
INTERVENTIONAL
2006-03-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
gefitinib
Gefitinib
oral tablet
2
Carboplatin/Paclitaxel
Carboplatin
IV
Paclitaxel
IV
Interventions
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Gefitinib
oral tablet
Carboplatin
IV
Paclitaxel
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer)
Exclusion Criteria
* Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Alison Armour, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Fuzhou, Fujian, China
Research Site
Guangzhou, Guangdong, China
Research Site
Wuhan, Hubei, China
Research Site
Nanjing, Jiangsu, China
Research Site
Dalian, Liaoning, China
Research Site
Chongqing, Sichuan, China
Research Site
Beijing, , China
Research Site
Chengdu, , China
Research Site
Hangzhou, , China
Research Site
Shanghai, , China
Research Site
Hong Kong, , Hong Kong
Research Site
Semarang, Central Java, Indonesia
Research Site
Malang, East Java, Indonesia
Research Site
Jakarta, , Indonesia
Research Site
Solo, , Indonesia
Research Site
Surabaya, , Indonesia
Research Site
Yogyakarta, , Indonesia
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Okazaki, Aichi-ken, Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kanazawa, Ishikawa-ken, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Ōmura, Nagasaki, Japan
Research Site
Okayama, Okayama-ken, Japan
Research Site
Izumisano, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Sayama, Osaka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
Research Site
Koto-ku, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Ube, Yamaguchi, Japan
Research Site
Kota Kinabalu, Sabah, Malaysia
Research Site
George Town, , Malaysia
Research Site
Kampung Baharu Nilai, , Malaysia
Research Site
Kuala Lumpur, , Malaysia
Research Site
Petaling Jaya, , Malaysia
Research Site
Cebu City, , Philippines
Research Site
Manila, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Singapore, , Singapore
Research Site
Changhua, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Chiang Mai, , Thailand
Research Site
Khon Kaen, , Thailand
Research Site
Songkhla, , Thailand
Countries
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References
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Nagase M, Aksenov S, Yan H, Dunyak J, Al-Huniti N. Modeling Tumor Growth and Treatment Resistance Dynamics Characterizes Different Response to Gefitinib or Chemotherapy in Non-Small Cell Lung Cancer. CPT Pharmacometrics Syst Pharmacol. 2020 Mar;9(3):143-152. doi: 10.1002/psp4.12490. Epub 2020 Feb 7.
Wu YL, Saijo N, Thongprasert S, Yang JC, Han B, Margono B, Chewaskulyong B, Sunpaweravong P, Ohe Y, Ichinose Y, Yang JJ, Mok TS, Young H, Haddad V, Rukazenkov Y, Fukuoka M. Efficacy according to blind independent central review: Post-hoc analyses from the phase III, randomized, multicenter, IPASS study of first-line gefitinib versus carboplatin/paclitaxel in Asian patients with EGFR mutation-positive advanced NSCLC. Lung Cancer. 2017 Feb;104:119-125. doi: 10.1016/j.lungcan.2016.11.022. Epub 2016 Nov 30.
Yang JC, Wu YL, Chan V, Kurnianda J, Nakagawa K, Saijo N, Fukuoka M, McWalter G, McCormack R, Mok TS. Epidermal growth factor receptor mutation analysis in previously unanalyzed histology samples and cytology samples from the phase III Iressa Pan-ASia Study (IPASS). Lung Cancer. 2014 Feb;83(2):174-81. doi: 10.1016/j.lungcan.2013.11.021. Epub 2013 Dec 1.
Wu YL, Fukuoka M, Mok TS, Saijo N, Thongprasert S, Yang JC, Chu DT, Yang JJ, Rukazenkov Y. Tumor response and health-related quality of life in clinically selected patients from Asia with advanced non-small-cell lung cancer treated with first-line gefitinib: post hoc analyses from the IPASS study. Lung Cancer. 2013 Aug;81(2):280-7. doi: 10.1016/j.lungcan.2013.03.004. Epub 2013 Mar 26.
Wu YL, Chu DT, Han B, Liu X, Zhang L, Zhou C, Liao M, Mok T, Jiang H, Duffield E, Fukuoka M. Phase III, randomized, open-label, first-line study in Asia of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer: evaluation of patients recruited from mainland China. Asia Pac J Clin Oncol. 2012 Sep;8(3):232-43. doi: 10.1111/j.1743-7563.2012.01518.x. Epub 2012 Apr 23.
Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.
Other Identifiers
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Iressa Pan Asian Study (IPASS)
Identifier Type: -
Identifier Source: secondary_id
D791AC00007
Identifier Type: -
Identifier Source: org_study_id