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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515902-15-00 | EU Trial (CTIS) Number | ||
| 2020-002683-31 | EudraCT Number |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab/Platinum/Etoposide | Experimental | Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival. | appr. 72 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | According to RECIST v1.1 as assessed by local investigator. | appr. 72 months |
| Immune Objective Response Rate (iORR) | According to iRECIST as assessed by local investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoints in defined molecular subtypes (NSCLC-type / SCLC-type) | appr. 72 months | |
| Quality of Life assessed by EORTC QLQ-C30. | appr. 72 months | |
| Quality of Life assessed by EORTC QLQ-LC13. |
Inclusion Criteria:
Written informed consent
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%)
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)
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Wermke, Prof. Dr. | Technische Universität Dresden (TUD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik | Berlin | 10117 | Germany | |||
| Evangelische Lungenklinik |
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| appr. 72 months |
| Disease Control Rate (DCR) | According to RECIST v1.1 as assessed by local investigator. | appr. 72 months |
| Progression Free Survival (PFS) | appr. 72 months |
| Immune Progression Free Survival (iPFS) | appr. 72 months |
| Duration of Response (DoR) | appr. 72 months |
| Progression Free Survival (PFS) rate at one year | 1 year |
| Immune Progression Free Survival (iPFS) rate at one year | 1 year |
| Overall survival at one year | 1 year |
| Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0). | appr. 72 months |
| appr. 72 months |
| Immune Effectors | Changes in cellular and humoral immune effectors in peripheral blood and their correlation with response. | appr. 72 months |
| Mutational Landscape | Mutational landscape of LCNEC in comparison to SCLC as well as squamous and Adenocarcinoma of the lung. The analysis will be using whole genome sequencing. | appr. 72 months |
| Tumor DNA (tDNA) level | Dynamics of circulating tumor DNA levels (changes from baseline). | appr. 72 months |
| Therapy Resistance | Mechanisms of therapy resistance (changes of immune invasion and mutational landscape in tumor re-biopsy upon progression). | appr. 72 months |
| Berlin |
| 12125 |
| Germany |
| Klinikum der Universität zu Köln, Klinik I für Innere Medizin | Cologne | 50937 | Germany |
| Universitätsklinikum Dresden, Medizinische Klinik 1 | Dresden | 01307 | Germany |
| Klinikum der J.W. Goethe Universität, Medizinische Klinik II | Frankfurt am Main | 60590 | Germany |
| Asklepios Fachkliniken München-Gauting | Gauting | 82131 | Germany |
| LungenClinic Grosshansdorf GmbH | Großhansdorf | 22927 | Germany |
| Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH | Halle | 06110 | Germany |
| Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH | Hemer | 58675 | Germany |
| Lungenfachklinik Immenhausen | Immenhausen | 34376 | Germany |
| Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik | Mainz | 55131 | Germany |
| Pius Hospital, Klinik für Hämatologie und Onkologie | Oldenburg | 26121 | Germany |
| Robert-Bosch-Krankenhaus GmbH | Stuttgart | 70376 | Germany |
| Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin | Winnenden | 71364 | Germany |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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