Consistency of PD-L1 Detecting Method Between E1L3N and 22C3 Monoclonal Antibodies in NSCLC Patients

Non Small Cell Lung Cancer Clinical Trial

— CONFIDENCE  

Official title:

Consistency of Immunohistochemical Detecting Assays Using E1L3N and 22C3 Monoclonal Antibodies for Detection of PD-L1 Expression in NSCLC Patients: A Prospective CONFIDENCE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129462
• Other study ID #: CONFIDENCE
• Status: Completed
• Start date: August 5, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2021
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluated the correlation between the qualitative test results of Xiamen Aide PD-L1 antibody reagent (immunohistochemistry) and the efficacy of Keytruda single-agent therapy, and the research data is used to support the registration and marketing of the assessment reagent

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 1, 2021
• Est. primary completion date: September 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. =18,advanced non-small cell lung cancer confirmed by histopathology, and have received K-drug mono-therapy in the past, the return visit information is complete, with traceable information such as tumor imaging examinations before and after treatment, and the curative effect can be judged;

2. Able to provide FFPE samples with a storage life of 4 years: 6 slices of continuous slices with a thickness of 3-5µm

Exclusion Criteria:

1. Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells <100);

2. K-drug mono-therapy is neoadjuvant therapy or adjuvant therapy;

3. Other situations that the investigator thinks are not suitable for participating in this clinical study

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistency	the consistency of PD-L1 expression between monoclonal antibodies of E1L3N and 22C3	August 2018- September 2021
Secondary	PFS	Progression free survival time	August 2018- September 2021
Secondary	ORR	Objective response rate	August 2018- September 2021