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

NCT05129462 | Completed

• 1 other identifier: CONFIDENCE
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Consistency

  the consistency of PD-L1 expression between monoclonal antibodies of E1L3N and 22C3

  August 2018- September 2021

Secondary Outcomes (2)

• PFS

  August 2018- September 2021

• ORR

  August 2018- September 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \<100);
• K-drug mono-therapy is neoadjuvant therapy or adjuvant therapy;
• Other situations that the investigator thinks are not suitable for participating in this clinical study

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue sample and plasma DNA

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yongchang Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: August 5, 2018
• Primary Completion: September 5, 2021
• Study Completion: October 1, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-11

Locations

CN (1)