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

University Hospital, Lille

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04589013

2019_06

2019-A03156-51 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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