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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04324125
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Information provided by (Responsible Party):
Yongchang Zhang, Hunan Province Tumor Hospital

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.

Condition or disease
Non Small Cell Lung Cancer

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

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Chemotherapy or Chemotherapy Plus PD-1 Antibody in HER 2 Insertion or Amplification Advanced Non-small Cell Lung Cancer
Actual Study Start Date : March 24, 2020
Estimated Primary Completion Date : March 24, 2021
Estimated Study Completion Date : March 24, 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. PFS [ Time Frame: may 2020- may 2021 (1 year) ]
    Progression free survival

Secondary Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
tissue sample and plasma DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
HER 2 Insertion or Amplification Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04324125

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Contact: Yongchang Zhang, MD +8613873123436 ext 7+861383123436
Contact: Nong Yang, MD +8613055193557 ext +8613873123436

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China, Hunan
Yongchang Zhang Recruiting
Changsha, Hunan, China, 410013
Contact: Yongchang Zhang, MD    +8613873123436 ext +8613873123436   
Sponsors and Collaborators
Hunan Province Tumor Hospital
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Principal Investigator: Yongchang Zhang, MD Hunan Cancer Hospital
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Responsible Party: Yongchang Zhang, professor, Hunan Province Tumor Hospital Identifier: NCT04324125    
Other Study ID Numbers: CRONUS
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms