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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04589013

Acronym

PRINCE

Enrollment

106

Registered

2020-10-19

Start date

2020-11-19

Completion date

2023-09-29

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results