NCT06494241

Brief Summary

To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

46 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Nov 2024Nov 2027

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

November 22, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

July 2, 2024

Last Update Submit

January 29, 2026

Conditions

Keywords

Epidermal Growth Factor ReceptorNSCLCNon-small cell lung cancerOsbervational

Outcome Measures

Primary Outcomes (2)

  • To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP

    Molecular testing-rate for the first-line treatment: Defined as the number of participants received molecular testing for the first-line treatment divided by total participants.

    Approximately 1 month after last patient in

  • To evaluate the treatment pattern in metastatic NSCLC patients after QIP

    TKIs first-line treatment rate: Defined as TKIs first-line treatment rate in AGA positive participants.

    Approximately 1 month after last patient in

Secondary Outcomes (6)

  • To evaluate the clinical outcomes in metastatic NSCLC patients after QIP

    Follow up approximately 24 months after last patient in

  • To evaluate the treatment pattern in metastatic NSCLC patients after QIP

    Approximately 1 month after last patient in

  • To evaluate the treatment pattern in metastatic NSCLC patients after QIP

    Approximately 1 month after last patient in

  • To evaluate the clinical outcomes in metastatic NSCLC patients after QIP

    Follow up approximately 24 months after last patient in

  • To evaluate the clinical outcomes in metastatic NSCLC patients after QIP

    Follow up approximately 24 months after last patient in

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients newly pathologic diagnosed metastatic NSCLC (clinical stage IV) or recurrent metastatic NSCLC will be enrolled. Approximately 1000 patients will be enrolled from about 50 sites in China.

You may qualify if:

  • Age ≥18 years, at the time of signing the informed consent.
  • ECOG performance status 0-2.
  • Newly pathologic diagnosed metastatic NSCLC (clinical stage IV) or recurrent metastatic NSCLC.

You may not qualify if:

  • Be participating in other intervention clinical trials.
  • Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • Previous enrolment in the other QIP study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (46)

Research Site

Anning, China

Location

Research Site

Anqing, China

Location

Research Site

Changzhi, China

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Research Site

Daqing, China

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Research Site

Dazhou, China

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Research Site

Dazhu, China

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Dingzhou, China

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Ganzhou, China

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Research Site

Guangzhou, China

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Guang’an, China

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Hanzhong, China

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Hebi, China

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Hengyang, China

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Huaibei, China

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Jining, China

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Jinzhou, China

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Liyang, China

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Lu'an, China

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Meihekou, China

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Nanchong, China

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Nanyang, China

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Ningde, China

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Ningxiang, China

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Panjin, China

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Pingxiang, China

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Quanzhou, China

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Shengzhou, China

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Suzhou, China

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Taizhou, China

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Tancheng, China

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Tongling, China

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Wafangdian, China

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Weifang, China

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Wuzhou, China

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Xiangtan, China

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Research Site

Xianning, China

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Xiantao, China

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Xixian, China

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Xuzhou, China

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Research Site

Yangjiang, China

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Yangzhou, China

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Yibin, China

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Yichun, China

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Research Site

Yingkou, China

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Research Site

Zhangjiakou, China

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Research Site

Zhuji, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Condition Hierarchy (Ancestors)

Bronchial Diseases

Study Officials

  • Yilong WU

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

November 22, 2024

Primary Completion (Estimated)

November 28, 2027

Study Completion (Estimated)

November 28, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Qualified researchers 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.

Shared Documents
STUDY PROTOCOL, SAP
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.
More information

Locations