Clinical trial · Observational
Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)
Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Large Cell Lung Cancer | Lung Large Cell Carcinoma | ALIAS | 0.90 |
| Neuroendocrine Carcinoma of Lung (Diagnosis) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunohistochemistry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)
- timeFrame
- Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
- description
- 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 (4)
- measure
- Correlation of PD-L1 expression of tumour cells with clinical data
- timeFrame
- Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
- description
- Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available