Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 December 2021 |
Main ID: |
EUCTR2011-004942-16-IT |
Date of registration:
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02/03/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSATM 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSATM. - IMPRESS
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Scientific title:
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A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSATM 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSATM. - IMPRESS |
Date of first enrolment:
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06/03/2012 |
Target sample size:
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250 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004942-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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China
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Germany
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Hong Kong
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Hungary
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Italy
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Japan
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Russian Federation
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Spain
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Taiwan
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Contacts
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Name:
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Information Centre
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Address:
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Information Centre
20080
Information Centre
Italy |
Telephone:
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029801 1 |
Email:
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information.centre@astrazeneca.com |
Affiliation:
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AstraZeneca |
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Name:
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Information Centre
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Address:
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Information Centre
20080
Information Centre
Italy |
Telephone:
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029801 1 |
Email:
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information.centre@astrazeneca.com |
Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1)-Male or female patients aged 18 years or older 2)-Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally 3)-Patients with documented 'acquired resistance' on first line gefitinib 4)-Patients suitable to start cisplatin based pemetrexed combination chemotherapy. 5)-Provision of informed consent prior to any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria: 1)-Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). 2)-Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease 3)-Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer 4)-Any evidence of severe of uncontrolled systemic disease 5)-Treatment with an investigational drug within 4 weeks before randomization
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Non Small Cell Lung Cancer MedDRA version: 14.1
Level: LLT
Classification code 10066490
Term: Progression of non-small cell lung cancer
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: IRESSA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: GEFITINIB CAS Number: 184475-35-2 Current Sponsor code: AZD1839 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: 1. To evaluate overall survival (OS) 2. To evaluate Objective Response Rate (ORR) and Disease Control Rate (DCR) 3. To evaluate symptoms and Health related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire 4. To evaluate gefitinib safety and tolerability.
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Timepoint(s) of evaluation of this end point: for the study: until 190 PFS events
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Main Objective: To evaluate Progression Free Survival (PFS) in patients who have ''acquired resistance'' to first line gefitinib
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Primary end point(s): Progression Free Survival (PFS)
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Secondary Outcome(s)
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Secondary end point(s): 1) Overall survival (OS) 2) Object Response Rate (ORR) 3) Disease Control Rate (DCR) 4) Symptoms and HRQOL as measured by the FACT-L Trial Outcome Index (TOI) 5) Safety and tolerability
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Timepoint(s) of evaluation of this end point: 1) for the study: until 125 OS events 2) until progression or last evaluable assessment in absence of progression 3) until 6 weeks following progression 4) from randomization until treatment discontinuation 5) from consent to 30 days after discontinuation of study treatment
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Secondary ID(s)
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2011-004942-16-ES
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D791LC00001
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Source(s) of Monetary Support
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ASTRAZENECA AB
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Ethics review
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Status: Approved
Approval date: 24/01/2012
Contact:
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