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Recruiting NCT04324125

Chemotherapy Combined With Immunotherapy in HER 2 Insertion or Amplification Advanced NSCLC

Observational Non Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • PFS [Time frame: may 2020- may 2021 (1 year)]
Secondary outcome measures (2)
  • OS [Time frame: may 2020- may 2021 (1 year)]
  • ORR [Time frame: may 2020- may 2021 (1 year)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Yongchang Zhang — Changsha

Identifiers

NCT: NCT04324125 · CRONUS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗