Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck KGaA, Darmstadt, Germany
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Requirement for immunosuppressive treatment with the exception of inhalative corticosteroids or low-dose systemic corticosteroids (prednisone equivalent dose ≤10 mg/day)
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
Clareo Health | EMD 521873 Plus Radiotherapy in Non Small Cell Lung Cancer (NSCLC)
