Chemotherapy Combined With Immunotherapy in HER 2 Inserti... | NCT04324125

Studies
Chemotherapy Combined With Immunotherapy in HER 2 Insertion or Amplification Advanced NSCLC

NCT04324125

Sponsor

Hunan Province Tumor Hospital

Status

Recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

Not provided

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

Mar 24, 2020Actual

Primary Completion Date

Dec 24, 2024Estimated

Completion Date

Mar 24, 2025Estimated

First Submitted Date

Mar 25, 2020

First Submission Date that Met QC Criteria

Mar 25, 2020

First Posted Date

Mar 27, 2020Actual

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

This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in HER 2 insertion or amplification.

Detailed Description

Main enrolled criteria:

Her2 insertion advanced NSCLC Her 2 amplification advanced NSCLC Failed with standard chemotherapy No history of PD-1/ PD-L1 antibody using

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	Progression free survival	may 2020- may 2021 (1 year)

Secondary Outcomes

Measure	Description	Time Frame
OS	Overall survival	may 2020- may 2021 (1 year)
ORR	To measure the patients's overall response rate	may 2020- may 2021 (1 year)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
HER 2 Insertion or Amplification
First Diagnosis and Treatment
Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody

Exclusion Criteria:

Patients received antitumor treatment before
Patients with contraindication of chemotherapy
Pregnant or breast feeding women

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HER 2 Insertion or Amplification Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by NGS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yongchang Zhang, MD	Contact	+8613873123436	7+861383123436	zhangyongchang@csu.edu.cn
Nong Yang, MD	Contact	+8613055193557	+8613873123436	yangnong0217@163.com

Overall Officials

Name	Affiliation	Role
Yongchang Zhang, MD	Hunan Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yongchang Zhang	Recruiting	Changsha	Hunan	410013	China

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

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