Phase
Condition
N/ATreatment
Atezolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent
Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma ofthe lung (LCNEC) without curative treatment options (patients with mixed histologyare eligible if LCNEC is the predominant histology i.e. ≥50%)
Previously untreated with systemic therapy (note: patients relapsing after curativeradio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 monthsafter discontinuation of curative treatment)
Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)
ECOG performance status: 0-2
age ≥18 years
measurable disease according to RECIST v1.1
adequate organ function defined as:
ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases
Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases
Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60ml/min
Neutrophils ≥1 Gpt/l, Platelets >50 Gpt/l unless caused by bone marrowcarcinosis
Exclusion
Exclusion Criteria:
Symptomatic brain metastases (patients with asymptomatic brain metastases areallowed provided they are stable without steroid treatment for at least 3 weeks)
Severe autoimmune disease (patients with endocrine autoimmune disorders are allowedas long as they are on stable substitution treatment)
Severe uncontrolled infection
Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
Any prior treatment for metastatic disease
Study Design
Connect with a study center
Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik
Berlin, 10117
GermanySite Not Available
Evangelische Lungenklinik
Berlin, 12125
GermanySite Not Available
Universitätsklinikum Dresden, Medizinische Klinik 1
Dresden, 01307
GermanySite Not Available
Klinikum der J.W. Goethe Universität, Medizinische Klinik II
Frankfurt am Main, 60590
GermanySite Not Available
Asklepios Fachkliniken München-Gauting
Gauting, 82131
GermanySite Not Available
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
GermanySite Not Available
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle (Saale),
GermanySite Not Available
Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg
Heidelberg, 69126
GermanySite Not Available
Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
Hemer, 58675
GermanySite Not Available
Lungenfachklinik Immenhausen
Immenhausen, 34376
GermanySite Not Available
Klinikum der Universität zu Köln, Klinik I für Innere Medizin
Köln, 50937
GermanySite Not Available
Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik
Mainz, 55131
GermanySite Not Available
Pius Hospital, Klinik für Hämatologie und Onkologie
Oldenburg, 26121
GermanySite Not Available
Robert-Bosch-Krankenhaus GmbH
Stuttgart,
GermanySite Not Available
Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin
Winnenden, 71364
GermanySite Not Available
Universitätsklinikum Würzburg, Comprehensive Cancer Center Mainfranken
Würzburg, 97078
GermanySite Not Available
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