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NCT Number: NCT05470595

A 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Other outcomes

  1. Secondary efficacy endpoints in defined molecular subtypes (NSCLC-type / SCLC-type)

    Time frame: appr. 72 months

  2. Quality of Life assessed by EORTC QLQ-C30.

    Time frame: appr. 72 months

  3. Quality of Life assessed by EORTC QLQ-LC13.

    Time frame: appr. 72 months

  4. Immune Effectors

    Time frame: appr. 72 months

    Changes in cellular and humoral immune effectors in peripheral blood and their correlation with response.

  5. 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.

  6. Tumor DNA (tDNA) level

    Time frame: appr. 72 months

    Dynamics of circulating tumor DNA levels (changes from baseline).

  7. Therapy Resistance

    Time frame: appr. 72 months

    Mechanisms of therapy resistance (changes of immune invasion and mutational landscape in tumor re-biopsy upon progression).

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Acronym: LCNEC-ALPINE

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Jul 22, 2022
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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