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

Registration Number: EUCTR2011-004942-16-ES

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate Progression Free Survival (PFS) in patients who have ??acquired resistance?? to first line gefitinib;<br> Secondary Objective: 1. To evaluate overall survival (OS)<br> 2. To evaluate Objective Response Rate (ORR) and Disease Control Rate (DCR)<br> 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<br> 4. To evaluate the safety and tolerability in patients<br> ;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
<br> Secondary end point(s): 1) Overall survival (OS)<br> 2) Object Response Rate (ORR)<br> 3) Disease Control Rate (DCR)<br> 4) Symptoms and HRQOL as measured by the FACT-L Trial Outcome Index (TOI)<br> 5) Safety and tolerability<br> ;<br> Timepoint(s) of evaluation of this end point: 1) for the study: until 125 OS events<br> 2) until progression or last evaluable assessment in absence of progression<br> 3) until 6 weeks following progression<br> 4) from randomization until treatment discontinuation<br> 5) from consent to 30 days after discontinuation of study treatment<br>

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