A randomized phase III study of follow up with or without adjuvant Gefitinib(IressaTM) following chemotherapy in patients with advanced non-small cell lungcancer

Phase 1

• Conditions: Advanced Non Small Cell Lung Carcinoma; MedDRA version: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2004-001331-36-GB
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-26
• Study Completion: 2009-12-02
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

? Histologically and/or cytologically proven NSCLC.
? Patients with clinical stage IV or IIIB (with pleural fluid and/or supraclavicular nodes – provided not eligible for consolidation radiotherapy).
? Patients with brain metastases are eligible, provided the latter are asymptomatic after cranial irradiation. The latter should be ended for at least 4 weeks.
? WHO performance status 0-2 (cf. Appendix B)
? Age = 18 years
? Absence of progression after a minimum of 2 and a maximum of 6 cycles of platinum containing palliative first line chemotherapy; confirmation of objective response is not mandatory. Last response evaluation should be not older than 3 weeks before randomisation.
The criteria of response evaluation (WHO or RECIST) are left at the investigator’s discretion.
? Absence of grade 3/4 toxicity caused by prior chemotherapy (except alopecia)
? Absence of other malignant disease, unless in remission for at least 5 years. Patients with basal cell carcinoma of the skin or adequately treated superficial carcinoma of the cervix are eligible regardless of this interval.
? Patients of reproductive potential must agree to practice an effective contraceptive method.
Women of childbearing potential must not be pregnant or lactating.
? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
? Before patient randomization, written informed consent must be given according to
ICH/GCP, and national/local regulations.
Patients can only be randomized in this trial once.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Prior treatment with EGFR inhibitors
? History, signs or symptoms of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
? Concomitant use of the following drugs: phenytoin, carbamazepine, rifampicin,
phenobarbital or St John's Wort

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate in a prospective way a benefit in terms of overall survival and progression-free survival of Gefitinib (ZD1839, IressaTM) compared to placebo in patients with advanced non small cell lung cancer (NSCLC), who are not progressing on first line palliative induction chemotherapy.;Secondary Objective: ;Primary end point(s): To compare overall survival between adjuvant Gefitinib and placebo in patients not progressing on first line palliative chemotherapy for their advanced non-small cell lung cancer (NSCLC).