Clinical trial NCT00322452: First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia
Official title: Open Label, Randomised, Parallel Group, Multicentre, Ph III Study To Assess Efficacy, Safety & Tolerability Of Gefitinib (IRESSA™) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
Gefitinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-08
Enrollment: 1329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.


Eligibility criteria: Inclusion Criteria:

* Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology.
* 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:

* Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.
* Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.

Primary outcomes:
measure: Median Progression Free Survival (PFS) in Months
timeFrame: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).
Secondary outcomes:
measure: Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)
timeFrame: Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.
measure: Objective Tumour Response Rate According to RECIST
timeFrame: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).
measure: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Neurotoxicity
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Rashes/Acnes
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Diarrhoea
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Nausea
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Vomiting
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases
timeFrame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
measure: Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire
timeFrame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.
measure: Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire
timeFrame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.
measure: Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire
timeFrame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Dalian
country: China
facility: Research Site
state: Liaoning
city: Chongqing
country: China
facility: Research Site
state: Sichuan
city: Beijing
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Semarang
country: Indonesia
facility: Research Site
state: Central Java
city: Malang
country: Indonesia
facility: Research Site
state: East Java
city: Jakarta
country: Indonesia
facility: Research Site
city: Solo
country: Indonesia
facility: Research Site
city: Surabaya
country: Indonesia
facility: Research Site
city: Yogyakarta
country: Indonesia
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Okazaki
country: Japan
facility: Research Site
state: Aichi
city: Kashiwa
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Omura
country: Japan
facility: Research Site
state: Nagasaki
city: Izumisano
country: Japan
facility: Research Site
state: Osaka
city: Osakasayama
country: Japan
facility: Research Site
state: Osaka
city: Sakai
country: Japan
facility: Research Site
state: Osaka
city: Sunto-gun
country: Japan
facility: Research Site
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Ube
country: Japan
facility: Research Site
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Kota Kinabalu
country: Malaysia
facility: Research Site
state: Sabah
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Nilai
country: Malaysia
facility: Research Site
city: Penang
country: Malaysia
facility: Research Site
city: Petaling Jaya
country: Malaysia
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Songkla
country: Thailand
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alison Armour, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.