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

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

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

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with non-small cell lung cancer who have previously received single-agent K therapy

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2018
• Primary Completion (Actual): September 5, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 20, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CONFIDENCE (Alias Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No