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

Phase 2

Recruiting

• Conditions: HER2 Insertion Mutation Positive Advanced NSCLC
• Interventions: Drug: PD-1 Combined With Pyrotinib

• Registration Number: NCT04144569
• Lead Sponsor: Yongchang Zhang

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-30
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-27
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 Combined With Pyrotinib	PD-1 Combined With Pyrotinib	PD-1 combined With pyrotinib used fo first-line chemotherapy failedr HER2 Insertion mutation positive advanced NSCLC

Primary Outcome Measures

Name	Time	Method
PFS	Approximately 1 years	Progression free survival

Secondary Outcome Measures

Name	Time	Method
ORR	Approximately 1 years	To measure the patients's overall response rate
OS	Approximately 1 years	Overall survival

Trial Locations

Locations (1)

Hunan Provincal Tumor Hospital; 🇨🇳 Changsha, Hunan, China