NCT04144569

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5.9 years

First QC Date

October 28, 2019

Last Update Submit

September 17, 2024

Conditions

HER2 Insertion Mutation Positive Advanced NSCLC

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival

    Approximately 1 years

Secondary Outcomes (2)

  • ORR

    Approximately 1 years

  • OS

    Approximately 1 years

Study Arms (1)

PD-1 Combined With Pyrotinib

EXPERIMENTAL

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

Drug: PD-1 Combined With Pyrotinib

Interventions

PD-1 Combined With PyrotinibDRUG

PD-1 Combined With Pyrotinib

PD-1 Combined With Pyrotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

pyrotinib

Study Officials

  • Yongchang Zhang, MD

    Hunan Province Tumor Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436zhangyongchang@csu.edu.cn

Xiangyu Zhang, PhD

CONTACT

514775505@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

January 30, 2019

Primary Completion

December 30, 2024

Study Completion

December 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CN(1)