Large Cell Lung CancerEPNECNCT03305133
Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)
An observational study of Large Cell Lung Cancer and Neuroendocrine Carcinoma of Lung (Diagnosis), run by Groupe Francais De Pneumo-Cancerologie at 28 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Cell Lung Cancer, Neuroendocrine Carcinoma of Lung (Diagnosis)
- What is being tested?
- Immunohistochemistry
- How many people
- 86 participants
- Where
- 28 sitesFrance
- Study dates
- 26 Sep 2017to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting a large-cell NEC taken in charge by investigational centres between January 1st, 2014 and December 31st, 2016. Alive patients will be identified during disease follow-up visit as per the local current practice and the study will be then proposed to them at that time. For died patients, eligible patients will be identified by checking the files present at site by the Principal Investigator.
Who may be able to join
- Patients aged > or = 18 years
- Diagnosis of Large-cell NEC confirmed by centralised reading
- Tumoral materials available and readable for PD-L1 labeling
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
France28 sites
Site 12
Aix-en-Provence, 13100
Centre Hospitalier Universitaire
Angers, 49033
Centre Hospitalier D Argenteuil
Argenteuil, VAL D'oise, 95100
Site 05
Bastia, 20200
Site 22
Beauvais, 60021
Centre Hospitalier du Morvan
Brest, 29200
Site 43
Caen, 14000
Site 48
Clermont-Ferrand, 63000
Site 33
Créteil, 94010
Site 32
Elbeuf, 76503
Site 04
Gap, 05000
Centre Hospitalier Les Oudairies
La Roche-sur-Yon, 85000
Centre Hospitalier Universitaire DUPUYTREN
Limoges, 87042
Hospital du Cluzeau
Limoges, 87042
Site 00
Limoges
Centre Hospitalier Lyon Sud
Lyon, 69495
Site 25
Mantes-la-Jolie, 78200
Site 06
Marseille, 13274
Site 01
Meaux, 77108
Site 42
Orléans, 45032
Hospital Saint Antoine
Paris, 75012
Site 26
Paris, 75012
Site 19
Périgueux, 24019
Site 02
Reims, 51092
Site 18
Rouen, 76031
Site 17
Rouen, 76233
Site 14
Toulon, 83800
Site 11
Villefranche-sur-Saône, 69655
About this study
Official title: Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)
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.
- Being tested
- Immunohistochemistry
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunohistochemistryOther
The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)
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)
Measured: Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Secondary outcomes (4)
Correlation of PD-L1 expression of tumour cells with clinical data
Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification
Measured: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Objective Response Rate (ORR)
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
Measured: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Progression-free survival (PFS)
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
Measured: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Overall survival (OS)
OS defined as the time from first treatment start to death for any cause expressed in months
Measured: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start26 Sep 2017
- Primary completion14 Sep 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominque Arpin, MD, Principal investigator, Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305133
- Sponsor's protocol ID
- GFPC 03-2017
- Acronym
- EPNEC
- Status last verified
- Mar 2020
- First submitted
- 4 Oct 2017
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PD-L1 Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC) (EPNEC-GFPC 03-2017)
- ClinicalTrials.gov ID
- NCT03305133
- Acronym / sponsor ID
- EPNEC / GFPC 03-2017
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Groupe Francais De Pneumo-CancerologieUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting a large-cell NEC taken in charge by investigational centres between January 1st, 2014 and December 31st, 2016. Alive patients will be identified during disease follow-up visit as per the local current practice and the study will be then proposed to them at that time. For died patients, eligible patients will be identified by checking the files present at site by the Principal Investigator.
Key inclusion criteria (3 listed)
- Patients aged > or = 18 years
- Diagnosis of Large-cell NEC confirmed by centralised reading
- Tumoral materials available and readable for PD-L1 labeling
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunohistochemistryThe slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally. | Other | – |
Primary outcome
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)
4 secondary outcomes
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
Objective Response Rate (ORR)
Time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Progression-free survival (PFS)
Time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Overall survival (OS)
Time frame: Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominque Arpin, MD principal investigator
Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Large Cell Lung Cancer and Neuroendocrine Carcinoma of Lung (Diagnosis), run by Groupe Francais De Pneumo-Cancerologie at 28 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.