Efficacy and Safety of PEMbrolizumab PD-L1-positive (>50% of Tumor Cells), Advanced NSCL Cancer(PEMBREIZH)

Carcinoma, Non-Small-Cell Lung Clinical Trial

— PEMBREIZH  

Official title:

Efficacy (Systemic and Cerebral) and Safety of PEMbrolizumab PD-L1-positive (More Than 50% of Tumor Cells), Advanced Non-small-cell Lung Cancer : A Study of Real Life in Brittany .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05321212
• Other study ID #: PEMBREIZH (29BRC18.0260)
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: March 2, 2019

Study information

• Verified date: April 2022
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study was a French multicentric cross-sectional study retrospectively of 108 consecutive advanced NSCLC patients with a PD-L1 TPS ≥50% and without EGFR/ALK aberrations treated by pembrolizumab in first line.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically or cytologically confirmed NSCLC PD- L1 TPS = 50% stage III and IV WHO performance status of 0, 1 or 2 adequate organ function

Exclusion Criteria:

• previous EGFR or ALK aberrations positive test for hepatitis B or C virus indicating acute or chronic infection known history of testing positive for human immunodeficiency virus (HIV) severe, uncontrolled autoimmune disease.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Immunotherapy

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	CHIC de QUIMPER	Quimper

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival with pembrolizumab	time from initiation of pembrolizumab to the date of disease progression or death	time from initiation of pembrolizumab to the date of disease progression or death ( 20 months)