PD-1 Combined With Pyrotinib for Chemotherapy Failure HER... | NCT04144569

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

NCT04144569

Sponsor

Yongchang Zhang

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

HER2 Insertion Mutation Positive Advanced NSCLC

Interventions

PD-1 Combined With Pyrotinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2019Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 28, 2019

First Submission Date that Met QC Criteria

Oct 28, 2019

First Posted Date

Oct 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PD-1 Combined With Pyrotinib	Drug	PD-1 Combined With Pyrotinib	PD-1 Combined With Pyrotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	Progression free survival	Approximately 1 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yongchang Zhang, MD	Contact	+8613873123436	+8613873123436	zhangyongchang@csu.edu.cn
Xiangyu Zhang, PhD	Contact			514775505@qq.com

Overall Officials

Name	Affiliation	Role
Yongchang Zhang, MD	Hunan Province Tumor Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hunan Provincal Tumor Hospital	Recruiting	Changsha	Hunan	410013	China

Intervention Browse Module

MeSH Terms

ID	Term
C000622954	pyrotinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided