Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04324125

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongchang Zhang

Changsha, Hunan, 410013, China

Location status: Recruiting

Location contact

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. +8613873123436

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PFS

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

    Progression free survival

Secondary outcomes

  1. OS

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

    Overall survival

  2. ORR

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

    To measure the patients's overall response rate

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Yang, MD

CONTACT

[email protected]

+8613055193557 ext. +8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. 7+861383123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Mar 27, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.