Gene expression as predictive markers of outcome in non-small cell lung cancer patients (stage IIIB with pleural effusion and stage IV) treated with chemotherapy. Phase II trial of GOIRC. - ND

Conditions: patients with non-small cell lung cancer cells in stage IIIB (with supraclavicular lymphnode metastases and / or pleural effusion) or IV, not previously treated with chemotherapy for advanced disease
MedDRA version: 9.1Level: SOCClassification code 10029104

Registration Number: EUCTR2009-017094-38-IT

Lead Sponsor: GRUPPO ONCOLOGICO ITALIANO DI RICERCA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Histological or cytological confirmation of NSCLC Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Stage IIIB/IV) Samples for genetic research Age ≥ 18 years old and ≤ 72 or older ECOG PS 0-1 Measurable (uni-dimensional) disease by RECIST criteria in a lesion not previously irradiated or non-measurable disease Absolute neutrophil count greater than 1.5 x 109/L, platelet count greater than 100 x 109/L and haemoglobin greater than 10 g/dl Bilirubin level either normal or <1.5 x ULN, AST (SGOT) and ALT (SGPT) <2.5 x ULN Serum creatinine <1.5 x ULN or creatinine clearance >60 ml/min Provision of written informed consent Effective contraception for both, male and female pts, if the risk of conception exists
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

No prior chemotherapy regimens Radiotherapy within 2 weeks of study entry or about target lesion Current infection Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease) Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study Positive pregnancy test

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the activity, in terms of objective response rate, and the feasibility of a therapeutic approach in which the first-line chemotherapy is individualized based on the genetic characteristics of the tumor in patients with NSCLC advanced stage (IIIB / IV). Response to treatment is evaluated according to RECIST;Secondary Objective: Assess: - Progression free survival - Overall Survival - Toxicity (according to NCI CTC version 3.0, see Annex III) - Toxic deaths within 60 days after randomization.;Primary end point(s): The primary efficacy end points are: tumor response rate.

Secondary Outcome Measures