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)
Conditions
Interventions
Trade Name: IRESSA
Product Name: Gefitinib
Product Code: AZD1839
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: GEFITINIB
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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);Timepoint(s) of evaluation of this end point: for the study: until 190 PFS events | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China, France, Germany, Hong Kong, Hungary, Italy, Japan, Russian Federation, Spain, Taiwan
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed