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

Non-small Cell Lung Cancer Clinical Trial

— PRINCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589013
• Other study ID #: 2019_06
• Secondary ID: 2019-A03156-51
• Status: Recruiting
• Start date: November 19, 2020
• Est. completion date: November 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Sarah Humez, MD
• Phone: 0320445962
• Email: sarah.humez[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
France	Clcc Oscar Lambret Lille	Lille
France	Hop Calmette Chu Lille	Lille
France	CH Victor Provot	Roubaix
France	Clinique Teissier	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Discrimination index (concordance index=C-statistics) of the multiparametric model and model including that of the PD-L1 test.	Compare the discriminant power of the multiparametric model to that of the PD-L1 test alone.	At 1 year