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
- Conditions
- on Small Cell Lung CancerMedDRA version: 14.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004942-16-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 265
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 gefitinib safety and tolerability.;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: for the study: until 190 PFS events
- Secondary Outcome Measures
Name Time Method 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