EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)

This is an interventional treatment trial for Lung Cancer focused on measuring NSCLC, immunocytokine, radiation, interleukin-2, immunotherapy, maintenance therapy Read More

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC stage IIIb with malignant pleural effusion or stage IV
• Pulmonary primary tumor or at least one NSCLC metastasis in the lung measuring at least 1 cm in diameter and eligible for local radiation with 20 Gy
• Disease control (partial remission or stable disease) after 4 cycles of platinum-based first-line chemotherapy whereby the time between the last dose of first-line chemotherapy and start of trial treatment should not be longer than 8 weeks
• Male or female, aged ≥18 years of age
• Signed written informed consent
• Effective contraception for male and female subjects of childbearing age
• ECOG performance status 0 or 1
• Adequate hematological function defined by WBC ≥3 x 10^9/L, neutrophils ≥1.5 x 10^9/L, lymphocyte count ≥0.5 x 10^9/L, platelet count ≥100 x 10^9/L; hemoglobin ≥9 g/dL
• Estimated creatinine clearance ≥50 mL/min according to the Cockcroft - Gault formula or 24-h urine sampling
• Adequate hepatic function defined by a total bilirubin level ≤1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 x ULN

Exclusion Criteria:

• Requirement for immunosuppressive treatment with the exception of inhalative corticosteroids or low-dose systemic corticosteroids (prednisone equivalent dose ≤10 mg/day)
• Systemic autoimmune disease (e.g. lupus erythematodes, rheumatoid arthritis)
• Organ transplant recipients
• Active infections (including HIV, hepatitis B and C, tuberculosis)
• Known or clinically suspected brain metastases
• Active cardiovascular/cerebrovascular disease (e.g. symptomatic coronary vascular disease, congestive heart failure ≥ NYHA II, LVEF <50%, ventricular arrhythmia requiring medication, myocardial infarction or stroke) within previous 6 months
• Pericardial effusion
• Major impairment in pulmonary function: forced expir¬atory volume in 1 second (FEV1) <50% and diffusion capacity for carbon monoxide (DLCO) <50% of normal limit
• Any other significant disease that in the Investigator's opinion would exclude the subject from the trial
• Known conditions associated with necroses of non-tumor bearing tissues (e.g. esophageal or gastroduodenal ulcers, ischemic bowel disease, chronic inflammations)
• Pregnancy or lactation
• Radiotherapy, chemotherapy, major surgery, biological therapy or any investigational drug within 30 days prior to the start of trial treatment
• Requirement for concurrent systemic anticancer treatment (chemotherapy, biological therapy)
• Pretreatment with anti-EGFR antibodies or tyrosine kinase inhibitors
• Participation in another interventional clinical trial within the past 30 days before start of trial treatment
• Known alcohol or drug abuse
• Any psychiatric condition that would prohibit the understanding or rendering of the informed consent
• Legal incapacity or limited legal capacity