A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung
NCT ID: NCT05470595
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
67 participants
INTERVENTIONAL
2022-01-18
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atezolizumab/Platinum/Etoposide
Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion.
Atezolizumab
Atezolizumab (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Four cycles of combined immunochemotherapy 3qw will be follows by maintenance with atezolizumab monotherapy until progression.
Interventions
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Atezolizumab
Atezolizumab (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Four cycles of combined immunochemotherapy 3qw will be follows by maintenance with atezolizumab monotherapy until progression.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Technische Universität Dresden
OTHER
Responsible Party
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Principal Investigators
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Martin Wermke, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Technische Universität Dresden (TUD)
Locations
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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
Countries
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Other Identifiers
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2024-515902-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
2020-002683-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TUD-ALPINE-077
Identifier Type: -
Identifier Source: org_study_id