Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00770588

Purpose

This is a double blind, multicentre, randomized, placebo-controlled study. The eligible patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will recruit 296 male or female, histologically or cytologically diagnosed locally advanced or metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2. Patients must have completed 4 cycles of platinum based first line doublet chemotherapy without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the following: gemcitabine, paclitaxel, docetaxel, vinorelbine.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer (NSCLC)	Drug: Gefitinib Drug: Placebo	Phase IV

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Placebo-Controlled, Multicentre, Randomised, Parallel Group, Phase IV Trial to Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) Chinese Patients Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Front Line Standard Platinum-Based Chemotherapy

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PFS: progression free survival will be calculated by AstraZeneca from the tumour measurements per the RECIST criteria and/or the date of patient death. [ Time Frame: The PFS will be assessed from the time of randomisation to the date of any of the following event, whichever occur first: Objective progression is observed and documented and Death from any cause. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival (OS) [ Time Frame: The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died, OS will be censored for the analysis at the last date at which the patients were known to be alive. ] [ Designated as safety issue: No ]
ORR (Objective tumour response) & DCR (Disease control rate) [ Time Frame: The objective tumour response rate will be calculated as the percentage of patients with CR or PR. The disease control rate will be calculated as the percentage of patients with CR or PR or sustained SD≥6weeks. ] [ Designated as safety issue: No ]
Improvement in LCS (Lung Cancer Subscale) will be assessed from the 7-question LCS domain score in FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire. [ Time Frame: Overall improvement in LCS is defined as an improvement from baseline in the LCS domain score of 2 points or more maintained for at least 21 days. The LCS improvement rate will be calculated as the percentage of patients analysed with improvement. ] [ Designated as safety issue: No ]
Safety profiles will be assessed in terms of AEs and laboratory data/vital signs that will be collected for all patients. [ Time Frame: Appropriate descriptive of AEs and laboratory data/vital signs will be produced for the 2 treatments. Incidence and reasons for study drug dose modifications (interruptions or reductions) and withdrawals will be summarised by each treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment:	296
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Gefitinib Dose form: 250 mg/tablet; Route: oral; Frequency: 1 tablet per day; Duration: until to objective PD
2: Placebo Comparator	Drug: Placebo To match Gefitinib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed locally advanced or metastatic (stage=IIIB/IV) non-small cell lung cancer (NSCLC) before the front line chemotherapy. Note: sputum cytology alone is not acceptable
Patients have completed 4 cycles of first line platinum contained doublet chemotherapy without progression or intolerable toxicity.
Patients with PR or SD on study entry need to have one or more measurable lesions according to RECIST criteria.
The study treatment should be started at least 3 weeks (21 days) but no more than 6 weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since last tumour assessment.

Exclusion Criteria:

Prior exposure to monoclonal antibodies or small molecule inhibitors against EGFR receptors. (e.g. gefitinib, erlotinib, C225)
Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they are clinically stable and have been discontinued from steroid therapy for at least 4 weeks prior to first dose of study medication.
Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
Known biomarker status of one or more of the following: Tumour EGFR gene copy number, tumour EGFR gene mutation status, tumour EGFR protein expression.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770588

Contacts

Contact: AstraZeneca China Clinical Study Information

+86 21 52564555

James.mao@astrazeneca.com

Locations

China
Research Site	Recruiting
Beijing, China
Research Site	Recruiting
Shanghai, China
Research Site	Recruiting
Tianjin, China
China, Fujian
Research Site	Recruiting
Fuzhou, Fujian, China
China, Guangdong
Research Site	Recruiting
Guangzhou, Guangdong, China
China, Guangxi
Research Site	Recruiting
Nanning, Guangxi, China
China, Heilongjiang
Research Site	Recruiting
Harbin, Heilongjiang, China
China, Henan
Research Site	Recruiting
Zhengzhou, Henan, China
China, Hubei
Research Site	Recruiting
Wuhan, Hubei, China
China, Jiangsu
Research Site	Recruiting
Nanjing, Jiangsu, China
China, Jilin
Research Site	Recruiting
Changchun, Jilin, China
China, Liaoning
Research Site	Recruiting
Shengyang, Liaoning, China
China, Shandong
Research Site	Recruiting
Qingdao, Shandong, China
China, Shanxi
Research Site	Recruiting
Xi'an, Shanxi, China
China, Sichuan
Research Site	Recruiting
Chendu, Sichuan, China
China, Zhejiang
Research Site	Recruiting
Hangzhou, Zhejiang, China
Research Site	Recruiting
Wenzhou, Zhejiang, China

Sponsors and Collaborators

AstraZeneca

More Information

Responsible Party:	AstraZeneca (China) Pharmaceuticals ( Karen Atkin/VP, China R&D )
Study ID Numbers:	D7913L00071
Study First Received:	October 9, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00770588
Health Authority:	China: State Food and Drug Administration

Keywords provided by AstraZeneca:

non-small cell lung cancer (NSCLC)
Gefitinib

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Disease Progression
Gefitinib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009