PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC

December 25, 2023 updated by: Yongchang Zhang

the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer

The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Provincal Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Nong Yang, MD
        • Contact:
        • Principal Investigator:
          • Yongchang Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Advanced non-small cell lung cancer confirmed by histology or cytology
  • HER2 insertion mutation-positive
  • Failure with first-line standard chemotherapy
  • with measurable lesions.

Exclusion Criteria:

  • no measurable tumor lesions
  • Patients received PD-1 or Pyrotinib before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 Combined With Pyrotinib
PD-1 combined With pyrotinib used fo first-line chemotherapy failedr HER2 Insertion mutation positive advanced NSCLC
Drug: PD-1 Combined With Pyrotinib
PD-1 Combined With Pyrotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Approximately 1 years
Progression free survival
Approximately 1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Approximately 1 years
To measure the patients's overall response rate
Approximately 1 years
OS
Time Frame: Approximately 1 years
Overall survival
Approximately 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yongchang Zhang

Investigators

  • Principal Investigator: Yongchang Zhang, MD, Hunan Province Tumor Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2019

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 25, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • POETHIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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