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

• Register: EUCTR
• Last refreshed on: 18 April 2017
• Main ID: EUCTR2011-004942-16-DE
• Date of registration: 27/01/2012
• 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: 15/05/2012
• 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, Korea, Republic of, 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: 19.0 Level: LLT Classification code 10066490 Term: Progression of non-small cell lung cancer System Organ Class: 100000004864

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)

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

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

Primary end point(s): Progression Free Survival (PFS) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone.

Timepoint(s) of evaluation of this end point: An expected average of 48 weeks after last subject enrolled into our study

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1) An expected average of 48 weeks after last subject enrolled into our study
2) An expected average of 48 weeks after last subject enrolled into our study
3) An expected average of 48 weeks after last subject enrolled into our study
4) An expected average of 48 weeks after last subject enrolled into our study
5) From time of informed consent until 30 days after discontinuation of gefitinib/placebo treatment.

Secondary end point(s): 1) Overall survival (OS) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients
with Pemetrexed & Cisplatin alone.
2) Object Response Rate (ORR) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to
patients with Pemetrexed & Cisplatin alone.
3) Disease Control Rate (DCR) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to
patients with Pemetrexed & Cisplatin alone.
4) Symptoms and HRQOL as measured by the FACT-L Trial Outcome Index (TOI) in patients with
Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone.
5) Safety and tolerability: Adverse events, Serious adverse events, incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.

Secondary ID(s)

2011-004942-16-ES

D791LC00001

Source(s) of Monetary Support

AstraZenecaAB