Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Philogen S.p.A.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed unresectable stage III NSCLC
Males or females, age ≥ 18 years
Measurable lung lesion defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria.
ECOG performance status \< 3
Life expectancy of at least 12 weeks
Patients eligible for concurrent radiochemotherapy (cisplatin/vinorelbine; 60-66 Gy EBRT) at the discretion of the clinical investigator
Absolute neutrophil count \> 1.5 x 109/L, hemoglobin \> 9.0 g/dL and platelets \> 100 x 109/L
Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/Dl)
ALT and AST ≤ 2.5 x the upper limit of normal (5.0 x ULN for patients with hepatic involvement with tumor
Serum creatinine \< 1.5 x ULN
All toxic effects of prior therapy must have resolved to ≤ Grade 1 unless otherwise specified above
Negative serum pregnancy test (for women of child-bearing potential only) at screening
You may not be if
Patients with metastatic disease
Patients amenable for surgical resection of lung tumor lesions
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis \& Ti) or any cancer curatively treated \< 5 years prior to study entry
History of HIV infection or infectious hepatitis B or C
Presence of active infections (e.g. requiring antibimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
Inadequately controlled cardiac arrhythmias including atrial fibrillation
Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria)
