Clinical Effectiveness and Safety of SHR-A1811 in Chinese... | NCT07516015

Studies
Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC

NCT07516015

Sponsor

Nanjing Tianyinshan Hospital

Status

Not yet recruiting

Last Update Posted

Apr 7, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

NSCLC

Interventions

No Drug

Countries

Not provided

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 10, 2026Estimated

Primary Completion Date

Sep 30, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Mar 31, 2026

First Submission Date that Met QC Criteria

Mar 31, 2026

First Posted Date

Apr 7, 2026Actual

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

Mar 31, 2026

Last Update Posted Date

Apr 7, 2026Actual

Name	Class
Henan Cancer Hospital	OTHER_GOV

Description Module

Brief Summary

SHR-A1811 is an approved therapy for non-small cell lung cancer (NSCLC) in China. Despite the clinical trial evidence, there is no real-world data of SHR-A1811 used in Chinese lung cancer patients with HER2 alteration.

This real world, prospective study will assess the effectiveness and safety of SHR-A1811 in patients with locally advanced or metastatic, HER2-Altered NSCLC in real-world setting.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Drug	Other	This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on SHR-A1811 will be enrolled in this study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-related Adverse Events Graded ≥ 3		Baseline up to approximately 2 years

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS) by Investigator Assessment in Real-world Setting (rwPFS)		Baseline up to approximatley 2 years
Overall Survival		Baseline up to approximately 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years at signing informed consent form (ICF).
Pathologically documented unresectable and/or metastatic NSCLC.
Documented any known activating HER2 alteration.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
Patients who receive SHR-A1811 based on physicians' discretion (Newly received or just have started the first dose no longer than 3 months before enrollment).

Exclusion Criteria:

Has spinal cord compression or clinically active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.

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

NSCLC patients with HER2 alteration who receiveSHR-A1811 based on physicians' discretion will be enrolled.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yong Song	Contact	86 13851761392		yong.song@nju.edu.cn
Wenshu Qu	Contact			quws1980@163.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided