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

NCT04589013 | Completed

• 2 other identifiers: 2019_062019-A03156-51
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The dependent variable will be the cumulative incidence of death or progression under immunotherapy + chemotherapy at 1 year.

  Progression will be evaluated by CT imaging every 12 weeks and then every 9 weeks according to RECIST 1.1. The independent variables will be the 6 immunohistochemical markers (PD-L1, CD8, FoxP3, PD1, CD163, CD15) evaluated prior to the first injection of pembrolizumab + chemotherapy from the diagnostic tissue material.

  At 1 year

Secondary Outcomes (1)

• Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test.

  At 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients meeting the inclusion criteria will be selected in each of the centers (Lille CHU, Lille Centre Oscar Lambret, Valenciennes Clinique Teissier, Roubaix CH) by the onco-pneumologists and included in the study, after collecting the consent, at the start of treatment with pembrolizumab + chemotherapy in first line.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (4)

Clcc Oscar Lambret Lille

Lille, 59037, France

Location

Hop Calmette Chu Lille

Lille, 59037, France

Location

CH Victor Provot

Roubaix, France

Location

Clinique Teissier

Valenciennes, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sarah Humez

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: November 19, 2020
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (4)