Immune Response on Neoadjuvant Therapy in Non-small-cell Lung Cancer (NSCLC)

Inclusion Criteria:

Histology and staging of the disease

• Histological confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC.
• Anatomically and functionally resectable NSCLC stage IB (T2N0) stage II (T1-2 N1, T3 N0) or stage IIIA (T3 N1) (see TAKO guidelines 2006, www.tako.or.at)
• Measurable disease according to RECIST criteria

General conditions

• 18-80 years.
• WHO 0-2; life expectancy of more than 3 months
• Effective contraception for both male and female patients if the risk of conception exists
• Adequate respiratory function, sufficient for necessary surgical treatment
• Adequate hematological function (Hb > 10 g/dl, ANC > 2.0 x 10 9/L, platelets > 100 x 10 9/L).
• Adequate renal and hepatic functions: total bilirubin within normal limits, serum creatinine within normal limits, 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.

Initial work-up

• Complete initial work-up within three weeks prior to first infusion includes chest CT scan, abdominal CT-scan, brain CT scan if indicated, PET-scan, bronchoscopy and mediastinoscopy, pulmonary function. Within 7 days prior to inclusion laboratory investigations and biological work up.
• Signed initial consent prior to protocol specific procedures.

Exclusion Criteria:

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 neurological or psychiatric disorders, including dementia or seizure
• Active infection requiring i.v. antibiotics
• Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
• Current peripheral neuropathy WHO grade > 2

Prior or concurrent therapy

• Prior chemotherapy or immunotherapy for NSCLC
• Prior surgery or radiotherapy for NSCLC
• Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
• Concurrent continuous treatment with systemic steroids for antiemetic use, intermittent application is allowed

General conditions

• Pregnant (absence to be confirmed by ß-HCG-test) or lactating patients
• Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements
• Participation in other clinical trials with experimental agents or non approved medical procedures during study and within 30 days prior to study entry
• Psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with the study protocol.