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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Lung Cancer

Non Small Cell Lung Cancer

Treatments

Biological: EMD 521873

Study type

Interventional

Funder types

Industry

Identifiers

NCT00879866

EMR 62235-002

Details and patient eligibility

About

Primary trial objective in this single arm trial is to assess the safety and tolerability of Selectikine (EMD 521873) given in combination with and local tumor irradiation and to determine whether the maximum tolerated dose (MTD) is reached with EMD 521873 doses of up to 0.45 mg/kg.

Secondary objectives are to evaluate PK, immunogenicity, overall response, changes in tumor marker levels and circulating tumor cell numbers, progression-free survival and overall survival. Also, to evaluate biological/immune responses to EMD 521873.

NSCLC patients have to be stable (PR or SD) after first-line chemotherapy in order to be enrolled. A total of 12 to 24 patients are planned. Patients will remain on the dose throughout the trial. It is intended to administer at least 4 cycles (21 d each), or until progression or 2nd line therapy becomes necessary.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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