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

Phase 1

• Conditions: on Small Cell Lung Cancer; MedDRA version: 19.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-004942-16-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-27
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified