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

NCT ID: NCT04144569

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-30

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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Conditions

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HER2 Insertion Mutation Positive Advanced NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD-1 Combined With Pyrotinib

PD-1 combined With pyrotinib used fo first-line chemotherapy failedr HER2 Insertion mutation positive advanced NSCLC

Group Type EXPERIMENTAL

PD-1 Combined With Pyrotinib

Intervention Type DRUG

PD-1 Combined With Pyrotinib

Interventions

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PD-1 Combined With Pyrotinib

PD-1 Combined With Pyrotinib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yongchang Zhang

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yongchang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Hunan Province Tumor Hospital

Locations

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Hunan Provincal Tumor Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongchang Zhang, MD

Role: CONTACT

+8613873123436 ext. +8613873123436

Xiangyu Zhang, PhD

Role: CONTACT

Facility Contacts

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Nong Yang, MD

Role: primary

+86 731 89762323

Yongchang Zhang, MD

Role: backup

+86 731 89762327

Other Identifiers

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POETHIS

Identifier Type: -

Identifier Source: org_study_id

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