Efficacy of Osimertinib in Patients With Lung Cancer | NCT06174857

Studies
Efficacy of Osimertinib in Patients With Lung Cancer

NCT06174857

Sponsor

Hunan Province Tumor Hospital

Status

Unknown status

Last Update Posted

Dec 18, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Advanced 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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jun 15, 2025Estimated

Completion Date

Sep 15, 2025Estimated

First Submitted Date

Dec 8, 2023

First Submission Date that Met QC Criteria

Dec 8, 2023

First Posted Date

Dec 18, 2023Actual

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

Dec 8, 2023

Last Update Posted Date

Dec 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yongchang Zhang, Professor, Deputy Director of Thoracic Oncology Department, Hunan Province Tumor HospitalPrincipal Investigator

Lead Sponsor

Hunan Province Tumor HospitalOTHER

Collaborators

Not provided

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 is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression-free survival	From registration onto that step until death, or censored at the date of last contact.	3 years
Overall survival	From registration onto that step until death, or censored at the date of last contact.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be ≥18 years.
Provision of fully informed consent prior to any study specific procedures.
Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology.
According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

None

Accepts Healthy Volunteers

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

advanced or metastatic (stage IV) lung cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yongchang C 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
Hunan Cancer hospital	Recruiting	Changsha	Hunan		China