Phase II Study with Gefitinib (sequentially) following Gemcitabine/Cisplatin as induction regimen for patients with stage IIIA N2 NSCLC.

• Conditions: Advanced Non Small-Cell Lung Carcinoma; MedDRA version: 7.0Level: LLTClassification code 10061873

• Registration Number: EUCTR2004-001332-23-BE
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-19
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

? Patients with pathologically proven primary NSCLC.
? Patients with clinical stage IIIa (N2) disease (Appendix G) documented on chest CT scan within 4 weeks prior to registration. Histological proof of N2-disease must be obtained by mediastinoscopy /-tomy, thoracotomy or VATS.
? Presence of at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional technique or as = 10 mm with spiral CT scan [conform to the RECIST criteria described on response evaluation (section 7.1)].
? Age > 18 years.
? WHO performance status = 2 (see Appendix B).
? The patient should be judged by the responsible thoracic surgeon to have irresectable N2-disease according to the local guidelines.
? The patient should be physically and mentally fit enough to receive Gemcitabine-Cisplatincontaining chemotherapy, and to undergo a lobectomy or pneumonectomy after induction therapy. A team consisting of the responsible pulmonologist, medical oncologist, thoracic surgeon, and radiotherapist should confirm the required fitness.
? No evidence of N3 or metastatic disease as assessed by physical examination, CT-scan of the thorax, bone scan and investigation of liver and adrenals by CT-scan or ultrasound.
? No superior vena cava syndrome.
? No pre-existing pleural or pericardial effusion.
? No pre-existing diffuse interstitial pulmonary fibrosis.
? No symptoms or signs of CNS involvement (CT-brain or MRI before entry is not mandatory in absence of neurological signs or symptoms).
? No pre-existing motor or sensory neurotoxicity = grade 2 (Common Toxicity Criteria).
? No active (uncontrolled) infection requiring i.v. antibiotics.
? No history of hypersensitivity to gefitinib or any excipient of gefitinib.
? No concomitant use of phenytoin, carbamazepine, rifampicine, barbiturates or St John's Wort.
? No prior therapy for NSCLC (chemotherapy, radiotherapy or surgery).
? No secondary primary malignancy except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and renal cell cancer).
? Use of any investigational agent in the month before enrolment in the study means ineligibility.
? No congestive heart failure or angina pectoris except if it is medically controlled. No previous history of myocardial infarction within 1 year prior to study entry nor uncontrolled hypertension or arrhythmia.
? Patients of reproductive potential must agree to practice an effective contraceptive method.
Women of childbearing potential must not be pregnant or lactating.
? Before patient registration, written informed consent to participate in the study and written informed consent to participate in the translational research part of this study,must be obtained and documented according to ICH/GCP, and national/local regulations.

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

Not provided

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal objective of the trial is to assess the therapeutic activity of Gemcitabine and Cisplatin sequentially followed by gefitinib (ZD1839, IressaTM) as an induction regimen in chemo-naïve patients with pathologically proven, stage IIIA N2 NSCLC scheduled for surgery after inductionchemotherapy.;Secondary Objective: ;Primary end point(s): The principal end-point is the assessment of a clinical Complete Response to induction treatment, as will be assessed according to a modified version of the RECIST criteria (see section 7.1 on Criteria of Evaluation). CT response will be confirmed at surgery. If a responding patient will not undergo<br>surgery for whatever reason response must be confirmed by repeat CT-scan and radical radiotherapy should follow.