Stage III NSCLC RWE in Chinese Patients

• Sponsor: AstraZeneca (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04023812
• Collaborator: (none)
• Enrollment: 500
• Locations: 25
• Anticipated Duration (Months): 45
• Patients Per Site: 20
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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. It is descriptive in nature and does not attempt to test any specific a priori hypotheses.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA)
• Actual Study Start Date: Jul 16, 2019
• Anticipated Primary Completion Date: Apr 16, 2023
• Anticipated Study Completion Date: Apr 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. To observe treatment patterns of unresectable, stage III NSCLC [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

Secondary Outcome Measures

1. To observe the clinical outcome of unresectable, stage III NSCLC [Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months]

   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.

2. To observe molecular testing patterns of stage III NSCLC [Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months]

   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.

3. To estimate parameters associated with radiation pneumonitis [Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months]

   Assessment of radiation pneumonitis observed with radiotherapy among patients with unresectable, stage III NSCLC

4. To observe adjuvant treatment patterns of resectable, stage III NSCLC [Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months]

   Adjuvant treatment received post surgery including chemotherapy, targeted therapy and radiotherapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 130 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	BeiJing		China	100020
2	Research Site	BeiJing		China	100044
3	Research Site	BeiJing		China
4	Research Site	ChangChun		China	130021
5	Research Site	ChengDu		China	610041
6	Research Site	ChengDu		China	610042
7	Research Site	DaTong		China	030000
8	Research Site	DaTong		China
9	Research Site	FenYang		China
10	Research Site	GuangZhou		China
11	Research Site	HeFei		China	330006
12	Research Site	HongKong		China
13	Research Site	JiNan		China	2501117
14	Research Site	NanNing		China	530021
15	Research Site	QingDao		China
16	Research Site	ShangHai		China	200030
17	Research Site	ShangHai		China	200040
18	Research Site	ShangHai		China
19	Research Site	ShanTou		China
20	Research Site	ShiJiaZhuang		China	050011
21	Research Site	ShiJiaZhuang		China	063000
22	Research Site	ShiJiaZhuang		China	430079
23	Research Site	TaiZhou		China
24	Research Site	TianJin		China
25	Research Site	YinChuan		China	750004

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT04023812
• Other Study ID Numbers: D4194R00009
• First Posted: Jul 18, 2019
• Last Update Posted: Jun 24, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AstraZeneca: prospective; observational; stage III NSCLC
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jun 24, 2022