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OpenTrials
Completed

NCT Number: NCT04589013

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clcc Oscar Lambret Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: At 1 year

    Compare the discriminant power of the multiparametric model to that of the PD-L1 test alone.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: PRINCE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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