Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
19–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Histology and staging of the disease
* Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC
* Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)
* Measurable disease (bidimensionally or unidimensionally according to WHO criteria)
2. General conditions
* Karnofsky Status \> 70, if age \> 70 years → PS \> 70
* Adequate hematological function (Hb \> 10 g/dl, ANC \> 2.0 x 109/L, platelets \> 100 x 109/L)
* Adequate renal and hepatic functions: total bilirubin \< 1 x upper normal limit (UNL), serum creatinine \< 1 x UNL, in case of limit value the creatinine clearance should be \> 60 ml/min, ASAT and ALAT \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL.
You may not be if
1. Diagnosis
* Evidence of brain metastases or other distant metastasis equivalent to stage IV disease
* History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
* Other serious concomitant illness or medical condition:
* Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia
* History of significant neurologic or psychiatric disorders, including dementia or seizure
* Active infection requiring i.v. Antibiotics
* Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
* Hepatic function abnormality: ASAT and/or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL
* Current peripheral neuropathy WHO grade \> 2
2. Prior or concurrent therapy
* Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant treatment
* Prior surgery or radiotherapy for NSCLC
* Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
3. General conditions
* Pregnant or lactating patients
* Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
