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

Last updated: January 17, 2025
Sponsor: Technische Universität Dresden
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Atezolizumab

Clinical Study ID

NCT05470595
TUD-ALPINE-077
2020-002683-31
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent

  2. 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%)

  3. 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)

  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:

  9. ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases

  10. Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases

  11. Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60ml/min

  12. Neutrophils ≥1 Gpt/l, Platelets >50 Gpt/l unless caused by bone marrowcarcinosis

Exclusion

Exclusion Criteria:

  1. Symptomatic brain metastases (patients with asymptomatic brain metastases areallowed provided they are stable without steroid treatment for at least 3 weeks)

  2. Severe autoimmune disease (patients with endocrine autoimmune disorders are allowedas 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

Study Design

Total Participants: 67
Treatment Group(s): 1
Primary Treatment: Atezolizumab
Phase: 2
Study Start date:
January 18, 2022
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik

    Berlin, 10117
    Germany

    Site Not Available

  • Evangelische Lungenklinik

    Berlin, 12125
    Germany

    Site Not Available

  • Universitätsklinikum Dresden, Medizinische Klinik 1

    Dresden, 01307
    Germany

    Site Not Available

  • Klinikum der J.W. Goethe Universität, Medizinische Klinik II

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Asklepios Fachkliniken München-Gauting

    Gauting, 82131
    Germany

    Site Not Available

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927
    Germany

    Site Not Available

  • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

    Halle (Saale),
    Germany

    Site Not Available

  • Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg

    Heidelberg, 69126
    Germany

    Site Not Available

  • Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

    Hemer, 58675
    Germany

    Site Not Available

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376
    Germany

    Site Not Available

  • Klinikum der Universität zu Köln, Klinik I für Innere Medizin

    Köln, 50937
    Germany

    Site Not Available

  • Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik

    Mainz, 55131
    Germany

    Site Not Available

  • Pius Hospital, Klinik für Hämatologie und Onkologie

    Oldenburg, 26121
    Germany

    Site Not Available

  • Robert-Bosch-Krankenhaus GmbH

    Stuttgart,
    Germany

    Site Not Available

  • Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin

    Winnenden, 71364
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg, Comprehensive Cancer Center Mainfranken

    Würzburg, 97078
    Germany

    Site Not Available

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