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Clinical Trials/NCT04324125
NCT04324125
Recruiting
N/A

Chemotherapy or Chemotherapy Plus PD-1 Antibody in HER 2 Insertion or Amplification Advanced Non-small Cell Lung Cancer

Hunan Province Tumor Hospital1 site in 1 country70 target enrollmentMarch 24, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Non Small Cell Lung Cancer
Sponsor
Hunan Province Tumor Hospital
Enrollment
70
Locations
1
Primary Endpoint
PFS
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in HER 2 insertion or amplification.

Detailed Description

Main enrolled criteria: Her2 insertion advanced NSCLC Her 2 amplification advanced NSCLC Failed with standard chemotherapy No history of PD-1/ PD-L1 antibody using

Registry
clinicaltrials.gov
Start Date
March 24, 2020
End Date
March 24, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hunan Province Tumor Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yongchang Zhang

professor

Hunan Province Tumor Hospital

Eligibility Criteria

Inclusion Criteria

  • ≥18,Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
  • HER 2 Insertion or Amplification
  • First Diagnosis and Treatment
  • Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody

Exclusion Criteria

  • Patients received antitumor treatment before
  • Patients with contraindication of chemotherapy
  • Pregnant or breast feeding women

Outcomes

Primary Outcomes

PFS

Time Frame: may 2020- may 2021 (1 year)

Progression free survival

Secondary Outcomes

  • ORR(may 2020- may 2021 (1 year))
  • OS(may 2020- may 2021 (1 year))

Study Sites (1)

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