A Prospective Non-randomized Study of 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy in Patients With Inoperable, Locally-advanced (Stage III) NSCLC
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Uncontrolled hypertension
- Ischemic peripheral vascular disease (Grade IIb-IV)
- History of an acute cardiac event such as myocardial infarction, instable angina
pectoris during the last 12 months
- Severe diabetic retinopathy
- Active autoimmune disease
- History of organ allograft or stem cell transplantation
- Recovery from major trauma including surgery within 4 weeks prior to administration
of study treatment
- Breast feeding female
- Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6
weeks before administration of study treatment
- Growth factors or immunomodulatory agents within 7 days of the administration of
study treatment (131I-L19SIP application).
- Hyperthyroidism or autonomous thyroid nodule