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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05129462

Acronym

CONFIDENCE

Enrollment

Registered

2021-11-22

Start date

2018-08-05

Completion date

2021-10-01

Last updated

2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Consistency	August 2018- September 2021	the consistency of PD-L1 expression between monoclonal antibodies of E1L3N and 22C3

Secondary

Measure	Time frame	Description
PFS	August 2018- September 2021	Progression free survival time
ORR	August 2018- September 2021	Objective response rate

Countries

China

Outcome results