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Prediction of Response to Treatment With Immunotherapy + Chemotherapy in Non-Small Cell Lung Cancer

NCT ID: NCT04589013

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2023-09-29

Brief Summary

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This study seeks to evaluate a multiparametric test including 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) to predict the cumulative incidence of death or progression on treatment with pembrolizumab+first line chemotherapy in metastatic non-small cell lung cancer, regardless of the PD-L1 status and in the absence of ALK, ROS1 or EGFR alteration.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 18 years at time of diagnosis
* Affiliation to a social insurance
* Obtaining the patient's non opposition
* Patients with non-small cell lung carcinoma, confirmed by anatomopathological, metastatic or locally advanced unresectable, not eligible for local curative treatment
* Cellular or tissue FFPE available
* Indication of treatment with pembrolizumab + first line chemotherapy in multidisciplinary consultation meeting
* No mutation of the EGFR gene, no rearrangement of ALK and ROS,
* At least one measurable tumor according to RECIST criteria

Exclusion Criteria

* Tissue or cellular FFPE not available
* Systemic anti-neoplastic or immunotherapy previously received except neoadjuvant or adjuvant treatment completed 6 months or more
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Humez

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Clcc Oscar Lambret Lille

Lille, , France

Site Status

Hop Calmette Chu Lille

Lille, , France

Site Status

CH Victor Provot

Roubaix, , France

Site Status

Clinique Teissier

Valenciennes, , France

Site Status

Countries

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France

Other Identifiers

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2019-A03156-51

Identifier Type: OTHER

Identifier Source: secondary_id

2019_06

Identifier Type: -

Identifier Source: org_study_id