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Clinical Trials in Germany / NCT05470595
Active, not recruiting Phase 2

A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung

NCT05470595 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2022-01-18
Last updated
2026-04-15

Condition(s) studied

Large Cell Neuroendocrine Carcinoma of the Lung

Investigational drug(s) / intervention(s)

Atezolizumab →

Atezolizumab: Atezolizumab (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Four cycles of combined immunochemotherapy 3qw will be followed by maintenance with atezolizumab monotherapy until progression.

Study summary

This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent 2. Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%) 3. Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment) 4. Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC) 5. ECOG performance status: 0-2 6. age ≥18 years 7. measurable disease according to RECIST v1.1 8. adequate organ function defined as: 1. ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases 2. Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases 3. Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault \>60 ml/min 4. Neutrophils ≥1 Gpt/l, Platelets \>50 Gpt/l unless caused by bone marrow carcinosis Exclusion Criteria: 1. Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks) 2. Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment) 3. Severe uncontrolled infection 4. Prior treatment with either Atezolizumab or other immune checkpoint inhibitor 5. Any prior treatment for metastatic disease

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik Berlin Germany
Evangelische Lungenklinik Berlin Germany
Klinikum der Universität zu Köln, Klinik I für Innere Medizin Cologne Germany
Universitätsklinikum Dresden, Medizinische Klinik 1 Dresden Germany
Klinikum der J.W. Goethe Universität, Medizinische Klinik II Frankfurt am Main Germany
Asklepios Fachkliniken München-Gauting Gauting Germany
LungenClinic Grosshansdorf GmbH Großhansdorf Germany
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH Halle Germany
Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg Heidelberg Germany
Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH Hemer Germany
Lungenfachklinik Immenhausen Immenhausen Germany
Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik Mainz Germany
Pius Hospital, Klinik für Hämatologie und Onkologie Oldenburg Germany
Robert-Bosch-Krankenhaus GmbH Stuttgart Germany
Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin Winnenden Germany

On this site

📄 Tecentriq (atezolizumab) drug profile →

More Technische Universität Dresden trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05470595 on ClinicalTrials.gov ↗ ← All trials in Germany