extensive disease, small cell lung cancer (ED-SCLC) MedDRA version: 14.1 Level: PT Classification code 10041071 Term: Small cell lung cancer stage unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: NA
Product Code: EMD 273066
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Interleukins
Current Sponsor code: EMD 273066
Concentration unit: mg milligram(s)
Concentratio
Sponsors
MERCK KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Signed written informed consent ? ≥18 years of age ? Histologically documented SCLC ? Radiologically demonstrated extensive-stage disease by thoracic and abdominal CT or MRI scan prior to induction chemotherapy ? Received 4 cycles of platinum-based, first-line chemotherapy (12-14 weeks) without thoracic irradiation ? Experienced a response to platinum-based, first-line chemotherapy (CR or PR according to RECIST shown after second and fourth course of induction chemotherapy compared to findings prior to induction therapy) ? Confirmatory CT or MRI scan ? Negative CT scan of the head ? Be enrolled and begin treatment 3-5 weeks after last infusion of platinum-based, first-line chemotherapy ? Life expectancy ≥4 months ? ECOG performance status ≤2 at study entry ? No clinical history of significantly impaired renal function or chronic kidney disease. Must have an estimated glomerular filtration rate ≥50 mL/min determined by the Cockgraft-Gault formula No significant haematologic abnormalities, including white blood cell count ≥2.5 × 103/μl (or total granulocytes ≥1 × 103/μl), absolute lymphocyte count ≥0.5 × 103/μl, platelet count ≥100 000/μl, and haemoglobin level >5.5 mmol/L ? No significant hepatic abnormalities, including alanine aminotransaminase and aspartate aminotransaminase ≤2.5 × the upper limit of normal (ULN), or ≤5 × ULN in case of liver metastasis, and total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Thoracic radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study ? ECG with evidence of active clinically significant cardiac disease within 4 weeks prior to starting study treatment and/or a cardiac stress test with abnormal results in subjects who have a history of signficant coronary heart disease (MI, angina pectoris, or high risk of uncontrolled arrhythmia) ? Uncontrolled CHF New York Heart Association Grade 2-4 or echocardiogram with a left ventricular ejection fraction <45%, or other signs of active clinically significant cardiovascular disease ? History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias unless controlled by an automatic internal cardiac defibrillator ? Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg) or hypotension (systolic blood pressure ≤80 mmHg requiring therapy beyond 24 hours) ? Evidence of active brain metastases ? No past history of neoplasm other than lung carcinoma, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years. ? Presence of medically significant third space fluids such as pleural or pericardial effusions or ascites requiring repetitive paracentesis, or oedema ≥Grade 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 ? Previous diagnosis of autoimmune disease involving major organ system or requirement for immunosuppressive therapy ? History of inflammatory bowel disease or history of acute or chronic bowel ischemia ? Significant active infection ? Legal incapacity or limited legal capacity that would interfer with informed consent or impair participation in the study ? Known hypersensitivity to Tween-80TM, human immunoglobulin, CTX, or any of the components of study treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine if exposure to EMD 273066 will increase the proportion of subjects with o Progression-free survival (PFS) at 6 months after randomisation;Secondary Objective: o To determine overall survival (OS) at 12 and 18 months (from beginning of first-line, platinumbased chemotherapy) o To determine median time to progression (TTP) after randomisation o To characterize the safety and tolerability of treatment with low-dose cyclosphosphamide(CTX) followed by EMD 273066 o To collect additional immunogenicity data from subjects exposed to EMD 273066 o To determine the objective response rate in subjects receiving second-line chemotherapy after disease progression;Primary end point(s): The primary efficacy endpoint for this study will be the number (and percentage) of subjects with PFS at 6 months after randomisation. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed