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: 9.1 Level: SOC Classification code 10029104
Conditions
Interventions
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Gemcitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical Form: P
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed