Extensive Stage Small Cell Lung Cancer
Conditions
Interventions
Group 1: This is a non-interventional study aimed at assessing the immune status of patients with ES-SCLC undergoing first-line therapy. For this purpose, participants will voluntarily provide up to f
Sponsors
Nucleic Acids to the Rescue GmbH (NUACRES®)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female and age =18 years; 2. Histologically confirmed ES-SCLC without prior systemic treatment 3. Patient deemed fit to receive local standard of care (SOC) with chemotherapy and immunotherapy 4. Eastern Cooperative Oncology Group (ECOG) Performance Status =1 and estimated life expectancy of =3 months; 5. Adequate organ function as evidenced by the following: a) Bone marrow function: hemoglobin =100 g/L; white blood cell (WBC) count =3.0 × 109/L; absolute neutrophil count (ANC) =1.5 × 109/L; platelet count =100 × 109/L. b) Hepatic: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 × upper limit of normal (ULN) (=5 × ULN if hepatic metastases present); bilirubin =1.5 × ULN; alkaline phosphatase =5.0 × ULN. c) Renal: creatinine <1.5 × ULN. 6. Patients of both genders with procreative potential must use effective contraception as appropriate based on the local hospital guidelines 7. Written informed consent obtained prior to conducting any study specific procedures
Exclusion criteria
Exclusion criteria: Patients who met any of the following criteria were excluded from participation in the study: 1. Chemotherapy, radiation, or any other anti-cancer therapies including any investigational agents within 4 weeks prior to study enrollment; however if the first cycle of first line treatment for ES-SCLC as specified in this protocol was already completed, these patients may be enrolled after the first cycle. 2. Major surgery within 4 weeks prior to entering the study and/or incomplete recovery from surgery or planned major surgery; 3. Primary or secondary auto-immune disease or immune deficiency; 4. Clinically active infections > Grade II according to the Common Terminology Criteria for Adverse Events (CTCAE); 5. Active hepatitis B or C 6. Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Note: Patients with a previous malignancy but without evidence of disease for = 12 months are allowed to enter the study; 7. Uncontrolled medical condition considered as high risk for a regular completion of the planned immunochemotherapeutic treatment, including unstable diabetes mellitus, or vena-cava-syndrome; 8. Symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV), unstable angina pectoris within 6 months prior to enrollment, significant cardiac arrhythmia, history of stroke, or transient ischemic attack within 1 year; 9. History of seizures, encephalitis, or multiple sclerosis; 10. Active drug abuse or chronic alcoholism; 11. Pregnant or breastfeeding. 12. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to evaluate the immune status based on a set of predefined biomarkers before starting chemo-immunotherapy for ES-SCLC, during the treatment and at time of a potential disease relapse. | — |
Countries
Germany
Contacts
Public ContactNikolaj Frost
Charité - Universitätsmedizin Berlin
Outcome results
None listed