Carcinoma, Non-Small-Cell LungNCT04023812
Stage III NSCLC RWE in Chinese Patients
An observational study of Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 25 sites in China.
Trial summary
The objectives of this study are to assess molecular testing, treatment patterns and associated clinical outcomes in Chinese patients with treatment-naïve stage III non-small cell lung cancer (NSCLC) in real world setting. This study is a prospective, non-interventional study. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 500 participants
- Where
- 25 sitesChina
- Study dates
- 16 Jul 2019to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage III NSCLC patients who received no prior systemic therapy for NSCLC before study enrolment
Who may be able to join
- Male or female aged 18 years or older.
- Provision of informed consent prior to any study specific procedures.
- Histologically or cytologically confirmed locally advanced, stage III NSCLC (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology).
Who cannot join
- Enrolment in studies that prohibit any participation in this observational study.
- Patients may be concurrently enrolled in unblinded clinical trials, but not blinded clinical trials in which the treatment being administered is unknown.
- Prior surgery, radiotherapy or systemic therapy for NSCLC, including chemotherapy, targeted therapy, anti-angiogenesis, etc.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Research Site
Beijing, China, 100020
Research Site
Beijing, China, 100044
Research Site
Beijing, China
Research Site
Changchun, 130021
Research Site
Chengdu, 610041
Research Site
Chengdu, 610042
Research Site
Datong, China, 030000
Research Site
Datong, China
Research Site
Fenyang, China
Research Site
Guangzhou, China
Research Site
Hefei, China, 330006
Research Site
Hong Kong
Research Site
Jinan, China, 2501117
Research Site
Nanning, China, 530021
Research Site
Qingdao, China
Research Site
Shanghai, 200030
Research Site
Shanghai, 200040
Research Site
Shanghai
Research Site
Shantou, China
Research Site
Shijiazhuang, 050011
Research Site
Shijiazhuang, 063000
Research Site
Shijiazhuang, 430079
Research Site
Taizhou, China
Research Site
Tianjin, China
Research Site
Yinchuan, China, 750004
About this study
Official title: Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA)
The objectives of this study are to assess molecular testing, treatment patterns and associated clinical outcomes in Chinese patients with treatment-naïve stage III non-small cell lung cancer (NSCLC) in real world setting. This study is a prospective, non-interventional study. It is descriptive in nature and does not attempt to test any specific a priori hypotheses.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- prospective, observational, stage III NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Cohort 1, including patients without surgical resection, will be defined as unresectable stage III NSCLC | |
| Cohort 2 | Cohort 2,including patients with surgical resection, will be defined as resectable stage III NSCLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe treatment patterns of unresectable, stage III NSCLC
Treatment received before disease progress including chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy and radiotherapy
Measured: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
Secondary outcomes (4)
To observe the clinical outcome of unresectable, stage III NSCLC
Overall survival measured from the date of treatment initiation in the study to the date of death due to any cause; Progression-free Survival (PFS) measured from the date of treatment initiation in the study, until physician-reported progression or death due to any cause, whichever occurs first.
Measured: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To observe molecular testing patterns of stage III NSCLC
Molecular testing patterns including:
Molecular testing rate defined as the number of patients who received molecular testing divided by total patient's number; Molecular testing details including sample type, test type; Molecular testing results.
Measured: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To estimate parameters associated with radiation pneumonitis
Assessment of radiation pneumonitis observed with radiotherapy among patients with unresectable, stage III NSCLC
Measured: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To observe adjuvant treatment patterns of resectable, stage III NSCLC
Adjuvant treatment received post surgery including chemotherapy, targeted therapy and radiotherapy.
Measured: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start16 Jul 2019
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023812
- Sponsor's protocol ID
- D4194R00009
- Status last verified
- Feb 2025
- First submitted
- 30 May 2019
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xing L, Yu J, Meng X, Zhao R, Yang W, Guo Y, Li J, Fan M, Xiao C, Ren Y, Dong L, Lv D, Zhao L, Lin Y, Zhang X, Chen L, Wang Y, Zhang Y, Zang A, Cheng G, Liu A, Liang N, Lou B, Wang J, Fu X, Shi A, Xu N, Liu J, Xiang ZL. Real-World Treatment Patterns and Clinical Outcomes Among Chinese Patients with Stage III NSCLC: The MOOREA Study. Target Oncol. 2026 May;21(3):385-398. doi: 10.1007/s11523-026-01217-0. Epub 2026 May 3.
PubMed 42070217
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA)
- ClinicalTrials.gov ID
- NCT04023812
- Acronym / sponsor ID
- D4194R00009
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- prospective, observational, stage III NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 18 Jul 2019 (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.
The objectives of this study are to assess molecular testing, treatment patterns and associated clinical outcomes in Chinese patients with treatment-naïve stage III non-small cell lung cancer (NSCLC) in real world setting. This study is a prospective, non-interventional study. It is descriptive in nature and does not attempt to test any specific a priori hypotheses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Cohort 1, including patients without surgical resection, will be defined as unresectable stage III NSCLC |
| Cohort 2 | – | –Cohort 2,including patients with surgical resection, will be defined as resectable stage III NSCLC |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage III NSCLC patients who received no prior systemic therapy for NSCLC before study enrolment
Key inclusion criteria (3 listed)
- Male or female aged 18 years or older.
- Provision of informed consent prior to any study specific procedures.
- Histologically or cytologically confirmed locally advanced, stage III NSCLC (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology).
Key exclusion criteria (3 listed)
- Enrolment in studies that prohibit any participation in this observational study.
- Prior surgery, radiotherapy or systemic therapy for NSCLC, including chemotherapy, targeted therapy, anti-angiogenesis, etc.
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 observe treatment patterns of unresectable, stage III NSCLC
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
Treatment received before disease progress including chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy and radiotherapy
4 secondary outcomes
To observe the clinical outcome of unresectable, stage III NSCLC
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To observe molecular testing patterns of stage III NSCLC
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To estimate parameters associated with radiation pneumonitis
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To observe adjuvant treatment patterns of resectable, stage III NSCLC
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 42070217Xing L, Yu J, Meng X, Zhao R, Yang W, Guo Y, Li J, Fan M, Xiao C, Ren Y, Dong L, Lv D, Zhao L, Lin Y, Zhang X, Chen L, Wang Y, Zhang Y, Zang A, Cheng G, Liu A, Liang N, Lou B, Wang J, Fu X, Shi A, Xu N, Liu J, Xiang ZL. Real-World Treatment Patterns and Clinical Outcomes Among Chinese Patients with Stage III NSCLC: The MOOREA Study. Target Oncol. 2026 May;21(3):385-398. doi: 10.1007/s11523-026-01217-0. Epub 2026 May 3.
- CSR Synopsis\_redactedLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 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, run by AstraZeneca at 25 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: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 observe treatment patterns of unresectable, stage III NSCLC (time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04023812, which also lists 1 linked publication.
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 18 Feb 2025.