First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia

NCT00322452 | Completed Phase 3 Results

• 2 other identifiers: D791AC00007Iressa Pan Asian Study (IPASS)
• Study Type: interventional
• Target: 1,329
• Locations: 9 countries
• Sites: 56

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLC; Gefitinib

Outcome Measures

Primary Outcomes (1)

• Median Progression Free Survival (PFS) in Months

  PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.

  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 (15)

• Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)

  Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.

• Objective Tumour Response Rate According to RECIST

  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).

• Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia

  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

• Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia

  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

• Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia

  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

Study Arms (2)

1

EXPERIMENTAL

gefitinib

Drug: Gefitinib

2

ACTIVE COMPARATOR

Carboplatin/Paclitaxel

Drug: Carboplatin; Drug: Paclitaxel

Interventions

Gefitinib DRUG

oral tablet

Also known as: Iressa, ZD1839

1

Carboplatin DRUG

IV

2

Paclitaxel DRUG

IV

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (56)

Research Site

Fuzhou, Fujian, China

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Guangzhou, Guangdong, China

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Wuhan, Hubei, China

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Nanjing, Jiangsu, China

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Dalian, Liaoning, China

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Chongqing, Sichuan, China

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Beijing, China

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Chengdu, China

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Hangzhou, China

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Shanghai, China

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Hong Kong, Hong Kong

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Semarang, Central Java, Indonesia

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Malang, East Java, Indonesia

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Jakarta, Indonesia

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Solo, Indonesia

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Surabaya, Indonesia

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Yogyakarta, Indonesia

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Nagoya, Aichi-ken, Japan

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Okazaki, Aichi-ken, Japan

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Kashiwa, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Sapporo, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Kanazawa, Ishikawa-ken, Japan

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Yokohama, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Ōmura, Nagasaki, Japan

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Okayama, Okayama-ken, Japan

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Izumisano, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai, Osaka, Japan

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Sayama, Osaka, Japan

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Sunto-gun, Shizuoka, Japan

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Bunkyo-ku, Tokyo, Japan

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Koto-ku, Tokyo, Japan

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Shinjuku, Tokyo, Japan

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Ube, Yamaguchi, Japan

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Kota Kinabalu, Sabah, Malaysia

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George Town, Malaysia

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Kampung Baharu Nilai, Malaysia

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Kuala Lumpur, Malaysia

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Petaling Jaya, Malaysia

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Cebu City, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Singapore, Singapore

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Changhua, Taiwan

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Kaohsiung City, Taiwan

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Taipei, Taiwan

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Taoyuan District, Taiwan

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Bangkok, Thailand

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Chiang Mai, Thailand

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Khon Kaen, Thailand

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Songkhla, Thailand

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Related Publications (6)

• 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.

  PMID: 31920008 DERIVED

• 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.

  PMID: 28212993 DERIVED

• 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.

  PMID: 24361280 DERIVED

• 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.

  PMID: 23540718 DERIVED

• 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.

  PMID: 22897752 DERIVED

• 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.

  PMID: 19692680 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

AZTrial_results_posting@AstraZeneca.com

Study Officials

• Alison Armour, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 8, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2010
• Last Updated: November 7, 2013
• Results First Posted: May 17, 2010

Record last verified: 2013-10

Locations

JP (22); TH (4); SG (1); CN (10); ID (6); PH (3); HK (1); TW (4); MY (5)