Carcinoma, Non-Small-Cell LungNCT06494241
Small/Middle Tier Cities and County Lung Cancer Quality Improvement Project (QIP) Study
An observational study of Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, run by AstraZeneca at 46 sites in China.
Trial summary
To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms
- How many people
- 1,000 participants
- Where
- 46 sitesChina
- Study dates
- 22 Nov 2024to 28 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
China46 sites
Research Site
Anning
Research Site
Anqing
Research Site
Changzhi
Research Site
Daqing
Research Site
Dazhou
Research Site
Dazhu
Research Site
Dingzhou
Research Site
Ganzhou
Research Site
Guang’an
Research Site
Guangzhou
Research Site
Hanzhong
Research Site
Hebi
Research Site
Hengyang
Research Site
Huaibei
Research Site
Jining
Research Site
Jinzhou
Research Site
Liyang
Research Site
Lu'an
Research Site
Meihekou
Research Site
Nanchong
Research Site
Nanyang
Research Site
Ningde
Research Site
Ningxiang
Research Site
Panjin
Research Site
Pingxiang
Research Site
Quanzhou
Research Site
Shengzhou
Research Site
Suzhou
Research Site
Taizhou
Research Site
Tancheng
Research Site
Tongling
Research Site
Wafangdian
Research Site
Weifang
Research Site
Wuzhou
Research Site
Xiangtan
Research Site
Xianning
Research Site
Xiantao
Research Site
Xixian
Research Site
Xuzhou
Research Site
Yangjiang
Research Site
Yangzhou
Research Site
Yibin
Research Site
Yichun
Research Site
Yingkou
Research Site
Zhangjiakou
Research Site
Zhuji
About this study
Official title: A Multi-Center Study to Evaluate the Guideline Education of Oncology Departments in Small/Middle Tier Cities and County Hospitals for Diagnosis and Treatment Improvement in Patients With Metastatic Non-small Cell Lung Cancer
To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.
Read the detailed description
The primary objective of this study is to assess the implementation of standardized diagnosis and treatment practice in oncology departments of Small/Middle tier cities and County hospitals, after standardized education and implementation of lung cancer clinical practice guidelines for oncology physicians.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms
- Keywords
- Epidermal Growth Factor Receptor, NSCLC, Non-small cell lung cancer, Osbervational
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 1 month after last patient in
Secondary outcomes (6)
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP
Progression Free Survival (PFS): Defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first.
Measured: Follow up approximately 24 months after last patient in
To evaluate the treatment pattern in metastatic NSCLC patients after QIP
1st/2nd/3rd generation EGFR-TKIs first-line treatment rate: Defined 1st/2nd/3rd generation EGFR-TKIs first-line treatment rate in EGFR positive participants.
Measured: Approximately 1 month after last patient in
To evaluate the treatment pattern in metastatic NSCLC patients after QIP
Immunotherapy first-line treatment rate: Defined as PD-1 or PD-L1 inhibitors first-line treatment rate in AGA negative participants.
Measured: Approximately 1 month after last patient in
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP
Response rate: Defined as the percentage of participants with the disease first-line treatment response by investigator assessment as recorded in CRF.
Measured: Follow up approximately 24 months after last patient in
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP
Disease control rate: Defined as the percentage of participants with the disease first-line treatment control by investigator assessment as recorded in CRF
Measured: Follow up approximately 24 months after last patient in
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP
Duration of Response: Defined as the time from first-line treatment response to disease progression or death in participants who achieve responding by investigator assessment as recorded in CRF.
Measured: Follow up approximately 24 months after last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start22 Nov 2024
- Primary completion28 Nov 2027 (estimated)
- Study completion28 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong WU, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494241
- Sponsor's protocol ID
- D5161L00048
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Evaluate the Guideline Education of Oncology Departments in Small/Middle Tier Cities and County Hospitals for Diagnosis and Treatment Improvement in Patients With Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06494241
- Acronym / sponsor ID
- D5161L00048
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms
- Keywords
- Epidermal Growth Factor Receptor, NSCLC, Non-small cell lung cancer, Osbervational
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 28 Nov 2027 (estimated)
- Study completion
- 28 Nov 2027 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.
Detailed description
The primary objective of this study is to assess the implementation of standardized diagnosis and treatment practice in oncology departments of Small/Middle tier cities and County hospitals, after standardized education and implementation of lung cancer clinical practice guidelines for oncology physicians.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP
Time frame: Approximately 1 month after last patient in
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.
To evaluate the treatment pattern in metastatic NSCLC patients after QIP
Time frame: Approximately 1 month after last patient in
TKIs first-line treatment rate: Defined as TKIs first-line treatment rate in AGA positive participants.
6 secondary outcomes
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP
Time frame: Follow up approximately 24 months after last patient in
To evaluate the treatment pattern in metastatic NSCLC patients after QIP
Time frame: Approximately 1 month after last patient in
To evaluate the treatment pattern in metastatic NSCLC patients after QIP
Time frame: Approximately 1 month after last patient in
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP
Time frame: Follow up approximately 24 months after last patient in
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP
Time frame: Follow up approximately 24 months after last patient in
To evaluate the clinical outcomes in metastatic NSCLC patients after QIP
Time frame: Follow up approximately 24 months after last patient in
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yilong WU principal investigator
Guangdong Provincial People's Hospital
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung and Lung Neoplasms, run by AstraZeneca at 46 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP (time frame: Approximately 1 month after last patient in). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.