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

Recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT04589013
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-19
• Study Start: 2020-11-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test.	At 1 year	Compare the discriminant power of the multiparametric model to that of the PD-L1 test alone.

Trial Locations

Locations (4)

Clcc Oscar Lambret Lille; 🇫🇷 Lille, France

Clinique Teissier; 🇫🇷 Valenciennes, France

Hop Calmette Chu Lille; 🇫🇷 Lille, France

CH Victor Provot; 🇫🇷 Roubaix, France