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

April 13, 2026 updated by: Technische Universität Dresden

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

This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik
      • Berlin, Germany, 12125
        • Evangelische Lungenklinik
      • Cologne, Germany, 50937
        • Klinikum der Universität zu Köln, Klinik I für Innere Medizin
      • Dresden, Germany, 01307
        • Universitätsklinikum Dresden, Medizinische Klinik 1
      • Frankfurt am Main, Germany, 60590
        • Klinikum der J.W. Goethe Universität, Medizinische Klinik II
      • Gauting, Germany, 82131
        • Asklepios Fachkliniken München-Gauting
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
      • Halle, Germany, 06110
        • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
      • Heidelberg, Germany, 69126
        • Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg
      • Hemer, Germany, 58675
        • Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
      • Immenhausen, Germany, 34376
        • Lungenfachklinik Immenhausen
      • Mainz, Germany, 55131
        • Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik
      • Oldenburg, Germany, 26121
        • Pius Hospital, Klinik für Hämatologie und Onkologie
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus GmbH
      • Winnenden, Germany, 71364
        • Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atezolizumab/Platinum/Etoposide
Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion.
Drug: Atezolizumab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
appr. 72 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: appr. 72 months
According to RECIST v1.1 as assessed by local investigator.
appr. 72 months
Immune Objective Response Rate (iORR)
Time Frame: appr. 72 months
According to iRECIST as assessed by local investigator.
appr. 72 months
Disease Control Rate (DCR)
Time Frame: appr. 72 months
According to RECIST v1.1 as assessed by local investigator.
appr. 72 months
Progression Free Survival (PFS)
Time Frame: appr. 72 months
appr. 72 months
Immune Progression Free Survival (iPFS)
Time Frame: appr. 72 months
appr. 72 months
Duration of Response (DoR)
Time Frame: appr. 72 months
appr. 72 months
Progression Free Survival (PFS) rate at one year
Time Frame: 1 year
1 year
Immune Progression Free Survival (iPFS) rate at one year
Time Frame: 1 year
1 year
Overall survival at one year
Time Frame: 1 year
1 year
Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0).
Time Frame: appr. 72 months
appr. 72 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary efficacy endpoints in defined molecular subtypes (NSCLC-type / SCLC-type)
Time Frame: appr. 72 months
appr. 72 months
Quality of Life assessed by EORTC QLQ-C30.
Time Frame: appr. 72 months
appr. 72 months
Quality of Life assessed by EORTC QLQ-LC13.
Time Frame: appr. 72 months
appr. 72 months
Immune Effectors
Time Frame: appr. 72 months
Changes in cellular and humoral immune effectors in peripheral blood and their correlation with response.
appr. 72 months
Mutational Landscape
Time Frame: appr. 72 months
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
Time Frame: appr. 72 months
Dynamics of circulating tumor DNA levels (changes from baseline).
appr. 72 months
Therapy Resistance
Time Frame: appr. 72 months
Mechanisms of therapy resistance (changes of immune invasion and mutational landscape in tumor re-biopsy upon progression).
appr. 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Martin Wermke, Prof. Dr., Technische Universität Dresden (TUD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2022

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-ALPINE-077
  • 2020-002683-31 (EudraCT Number)
  • 2024-515902-15-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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