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JOURNAL ONKOLOGIE – STUDIE
LCNEC-ALPINE

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

Rekrutierend

NCT-Nummer:
NCT05470595

Studienbeginn:
Januar 2022

Letztes Update:
02.11.2023

Wirkstoff:
Atezolizumab

Indikation (Clinical Trials):
Carcinoma, Neuroendocrine, Lung Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Technische Universität Dresden

Collaborator:
Roche Pharma AG

Studienleiter

Martin Wermke, MD
Principal Investigator
Technische Universität Dresden (TUD)

Kontakt

Studienlocations
(3 von 14)

Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin
71364 Winnenden
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Maria Netchaeva» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - appr. 72 months):
To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.



Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - appr. 72 months):
According to RECIST v1.1 as assessed by local investigator.

2. Immune Objective Response Rate (iORR) (Time Frame - appr. 72 months):
According to iRECIST as assessed by local investigator.

3. Disease Control Rate (DCR) (Time Frame - appr. 72 months):
According to RECIST v1.1 as assessed by local investigator.

4. Progression Free Survival (PFS) (Time Frame - appr. 72 months)

5. Immune Progression Free Survival (iPFS) (Time Frame - appr. 72 months)

6. Duration of Response (DoR) (Time Frame - appr. 72 months)

7. Progression Free Survival (PFS) rate at one year (Time Frame - 1 year)

8. Immune Progression Free Survival (iPFS) rate at one year (Time Frame - 1 year)

9. Overall survival at one year (Time Frame - 1 year)

10. Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0). (Time Frame - appr. 72 months)

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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

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