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Completed

NCT Number: NCT03305133

Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)

Observational, multicentre, retrospective study on patients taken care according to the national guidelines. The objective is to define, after the diagnosis confirmation, the frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad prognostic and there is no evidence of treatment for these patients with advanced disease in second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of cancer might have a major therapeutic impact in a close future to access immunotherapies.

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Key information

Conditions

Large Cell Lung Cancer Disease Neuroendocrine Carcinoma of Lung (Diagnosis) Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier D Argenteuil, Argenteuil, VAL D'oise, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged > or = 18 years
  • Diagnosis of Large-cell NEC confirmed by centralised reading
  • Tumoral materials available and readable for PD-L1 labeling

Exclusion criteria

  • Other type of Lung cancers
  • Tumoral material not available or not readable for centralised reading
  • Tumoral material not available or not readable for PD-L1 labeling

Treatment and study plan

immunohistochemistry

Other

The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.

Primary outcomes

  1. Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)

    Time frame: Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016

    Determine the frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)in terms of percentage of tumor cells expressing PD-L1 in immunohistochemistry (IHC) at the time of diagnosis:

    The frequency of PD-L1 expression determined by IHC will be as follow:

    • Negative PD-L1 tumours (<1% of positive tumour cells)
    • Positive PD-L1 tumours (> or = to 1% of positive tumour cells)
    • Low positive PD-L1 tumours (from 1% to 49% of positive tumour cells expressed)
    • High positive PD-L1 tumours (> or = 50% of positive tumour cells expressed)

Secondary outcomes

  1. Correlation of PD-L1 expression of tumour cells with clinical data

    Time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016

    Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification

  2. Objective Response Rate (ORR)

    Time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016

    Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) to a first line of treatment using RECIST 1.1 criteria as assessed locally

  3. Progression-free survival (PFS)

    Time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016

    PFS of the first line of treatment using RECIST 1.1 criteria assessed locally defined as the time from first treatment start to disease progression or death for any cause expressed in months

  4. Overall survival (OS)

    Time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016

    OS defined as the time from first treatment start to death for any cause expressed in months

Sponsors and collaborators

Lead sponsor

Groupe Francais De Pneumo-Cancerologie

Other

Registry information

Official study title

Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)

Acronym: EPNEC

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2017
Registry last updated
Mar 12, 2020

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

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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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