A phaseIII study of IRESSA treatment beyond progression in addition to Chemotherapy versus Chemotherapy alone

• Register: EUCTR
• Last refreshed on: 11 March 2020
• Main ID: EUCTR2011-004942-16-ES
• Date of registration: 23/12/2011
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A phaseIII study of IRESSA treatment beyond progression in addition to Chemotherapy versus Chemotherapy alone
• Scientific title: 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: 22/02/2012
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004942-16
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

China, France, Germany, Hong Kong, Hungary, Italy, Japan, Russian Federation, Spain, Taiwan

Contacts

• Name: Information Centre
• Affiliation: AstraZeneca

• Name: Information Centre
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

Inclusion criteria:
1)-Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 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:
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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

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)

Intervention(s)

Trade Name: IRESSA
Product Name: Gefitinib
Product Code: AZD1839
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

Primary Outcome(s)

Primary end point(s): Progression Free Survival (PFS)

Timepoint(s) of evaluation of this end point: for the study: until 190 PFS events

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 the safety and tolerability in patients

Main Objective: To evaluate Progression Free Survival (PFS) in patients who have ??acquired resistance?? to first line gefitinib

Secondary Outcome(s)

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

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

Secondary ID(s)

D791LC00001

Source(s) of Monetary Support

AstraZenecaAB

Ethics review

Status: Approved
Approval date: 08/02/2012
Contact: