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

NCT05470595 | Active Not Recruiting Phase 2

• 3 other identifiers: TUD-ALPINE-0772024-515902-15-002020-002683-31
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 15

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.

Conditions

Large Cell Neuroendocrine Carcinoma of the Lung

Keywords

Lung Cancer; LCNEC; Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Objective Response Rate (ORR)

  appr. 72 months

• Immune Objective Response Rate (iORR)

  appr. 72 months

• Disease Control Rate (DCR)

  appr. 72 months

• Progression Free Survival (PFS)

  appr. 72 months

• Immune Progression Free Survival (iPFS)

  appr. 72 months

Other Outcomes (7)

• 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.

  appr. 72 months

Study Arms (1)

Atezolizumab/Platinum/Etoposide

EXPERIMENTAL

Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion.

Drug: Atezolizumab

Interventions

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.

Atezolizumab/Platinum/Etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases
• Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases
• Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault \>60 ml/min
• Neutrophils ≥1 Gpt/l, Platelets \>50 Gpt/l unless caused by bone marrow carcinosis

You may not qualify if:

• Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
• Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
• Severe uncontrolled infection
• Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
• Any prior treatment for metastatic disease

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Roche Pharma AG: collaborator

Study Sites (15)

Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik

Berlin, 10117, Germany

Location

Evangelische Lungenklinik

Berlin, 12125, Germany

Location

Klinikum der Universität zu Köln, Klinik I für Innere Medizin

Cologne, 50937, Germany

Location

Universitätsklinikum Dresden, Medizinische Klinik 1

Dresden, 01307, Germany

Location

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

Frankfurt am Main, 60590, Germany

Location

Asklepios Fachkliniken München-Gauting

Gauting, 82131, Germany

Location

LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

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

Halle, 06110, Germany

Location

Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

Hemer, 58675, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

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

Mainz, 55131, Germany

Location

Pius Hospital, Klinik für Hämatologie und Onkologie

Oldenburg, 26121, Germany

Location

Robert-Bosch-Krankenhaus GmbH

Stuttgart, 70376, Germany

Location

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

Winnenden, 71364, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Neuroendocrine

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Martin Wermke, Prof. Dr.

  Technische Universität Dresden (TUD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 22, 2022
• Study Start: January 18, 2022
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

DE (15)