A Multi-centre Chart Review Study of Stage I-III Non-Smal... | NCT07316062

Studies
A Multi-centre Chart Review Study of Stage I-III Non-Small Cell Lung Cancer in China

NCT07316062

Sponsor

AstraZeneca

Status

Recruiting

Last Update Posted

Jun 11, 2026Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Non-Small-Cell Lung

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

Jun 2026

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

Apr 29, 2026Actual

Primary Completion Date

Apr 30, 2029Estimated

Completion Date

Apr 30, 2029Estimated

First Submitted Date

Dec 5, 2025

First Submission Date that Met QC Criteria

Dec 18, 2025

First Posted Date

Jan 5, 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

Jun 10, 2026

Last Update Posted Date

Jun 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 chart review study is proposed in China to understand the treatment patterns, biomarker testing, and clinical outcomes with SOC and some selected regimens among patients diagnosed with stage I-III NSCLC.

Detailed Description

The primary objective of this study is to understand the evolution of initial treatment patterns among patients with early-stage (I-III) NSCLC.

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

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment Patterns	Proportion of patients with different treatment regimens	Up to 50 months
Proportion of unresected patients in SI/II/III	Proportion of patients who are unresected among SI/II/III NSCLC patients enrolled, respectively	Up to 50 months
CRT rate in USIII	Proportion of patients who have CRT regimen among unresected SIII patients enrolled	Up to 50 months

Secondary Outcomes

Measure	Description	Time Frame
Treatment Duration	TKI treatment duration and discontinuation reason in EGFRm patients Duration of treatment Treatment discontinuation (time to discontinuation, and reason for discontinuation)	Up to 50 months
Patterns of recurrence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stage I-III at initial NSCLC diagnosis
Aged ≥18 years at first diagnosis of NSCLC
Timeframe of NSCLC diagnosis:

For DE1: diagnosed with NSCLC during the period between May 1st 2025 and December 31st 2025 For DE2: diagnosed with NSCLC during the period between May 1st 2026 and December 31st 2026 For DE3: diagnosed with NSCLC during the period between May 1st 2027 and December 31st 2027

Exclusion Criteria:

NSCLC is not the primary cancer diagnosis
Patients with a recent history of other tumor or concurrent other tumor
Patients participating in interventional clinical trials at time of initial diagnosis
Patients with positive pregnancy status at the time of diagnosis

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

The target population for this study will be patients diagnosed with stage I-III NSCLC treated in routine clinical practice with various treatment regimens (e.g., definitive treatment with surgery or radiotherapy, neoadjuvant, adjuvant and perioperative systemic therapies) who meet the study eligibility criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AstraZeneca Clinical Study Information Center	Contact	1-877-240-9479		information.center@astrazeneca.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Qualified investigators can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Types

Not provided

Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

URL

https://vivli.org/

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

Browse Leaves

Not provided

Browse Branches

Not provided