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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04144569

Enrollment

Registered

2019-10-30

Start date

2019-01-30

Completion date

2024-12-31

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2 Insertion Mutation Positive Advanced NSCLC

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

Interventions

DRUGPD-1 Combined With Pyrotinib

PD-1 Combined With Pyrotinib

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single Group Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PFS	Approximately 1 years	Progression free survival

Secondary

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

Countries

China

Contacts

Primary ContactYongchang Zhang, MD

zhangyongchang@csu.edu.cn+8613873123436

Backup ContactXiangyu Zhang, PhD

514775505@qq.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026