C34
Conditions
Interventions
Group 1: Patients will NSCLC will be examined for immunological signatures.
Sponsors
Nationales Centrum für Tumorerkrankungen (NCT)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients = 18 years, no upper age limit 2. Ability of the participant to understand the nature and scope of the clinical trial as well as full capacity of consent 3. Written informed consent 4. By imaging suspected primary, not locally curative treatable lung carcinoma 5. Possibility of an additional biopsy of the primary tumour or a metastasis as part of routine diagnostics during screening and during the study in case of discordant response with local progression of single leasons and stability of the remaining leasons, as well as after progression under /intolerance of first-line therapy as well as optionally after progression under/intolerance of second-line therapy 6. Possibility of collection (as defined in the protocol) of blood samples prior to start of treatment , after progression under /intolerance of first-line therapy , after progression under/intolerance of second-line therapy, as well as during possible additional biopsies. 7. Consent for the collection of blood and tissue samples that exceed the routine diagnostic 8. Histological evidence of NSCLC 9. No previous systemic palliative treatment of the NSCLC 10. Performance status ECOG 0-1 11. Adequate organ function defined as : • adequate hematological function (neutrophile granulocytes (absolute) =1000/µl, platelets=100.000/µl, hemoglobin =8.5 g/dl [5.6 mmol/l] (possible after transfusion)) • adequate kidney function (serum creatinine =1.5 mg/dl [114.5 µmol/l] or estimated creatinine clearance calculated with the formula by Cockroft and Gault =30 ml/min) • adequate liver function (serum bilirubine =2x ULN, AST/ALT =3x ULN, in case of liver metastasis AST/ALT =5x ULN)
Exclusion criteria
Exclusion criteria: 1. Patient is pregnant or lactating 2. Other simultaneous cancer treatments 3. HIV infection or active hepatitis B or C infection 4. Cardiovascular disease with o myocardial infarction (T-wave/Non-T-wave) within the last 3 months o unstable angina pectoris o class III or IV heart failure as defined by the New York Heart Association (NYHA) 5. Any clinically relevant bleeding within 2 weeks prior to the first planned biopsy 6. At time of screening, brain metastasis that are symptomatic. High degree of clinical suspicion is sufficient even without imaging. A previous neurosurgical brain metastasis resection, stereotactic radiotherapy or whole brain radiotherapy are allowed. 7. Any medical condition of the patient that in the opinion of the investigator limits the ability of the patient to finish the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; progression free survival, PFS. The primary endpoints will be determined until the individual clinical study end of the patient. The individuall clinical study end is reached within 24 months after start of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, OS. The survival status will be determined up to 5 years after begin of the first line therapy. | — |
Countries
Germany
Contacts
Public ContactTilmann Bochtler
Universitätsklinikum Heidelberg Thoraxklinik-Heidelberg gGmb
Outcome results
None listed