Clinical trial NCT04023812: Stage III NSCLC RWE in Chinese Patients
Official title: Real-World Molecular Testing, Treatment Patterns and Clinical Outcomes in Chinese Patients With Stage III NSCLC- A Prospective, Non-Interventional Study(MOOREA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: prospective
observational
stage III NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage III NSCLC patients who received no prior systemic therapy for NSCLC before study enrolment

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To observe treatment patterns of unresectable, stage III NSCLC
timeFrame: 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:
measure: To observe the clinical outcome of unresectable, stage III NSCLC
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
measure: To observe molecular testing patterns of stage III NSCLC
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
measure: To estimate parameters associated with radiation pneumonitis
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
measure: To observe adjuvant treatment patterns of resectable, stage III NSCLC
timeFrame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
Other outcomes:
Locations:
city: Bei Jing
country: China
facility: Research Site
city: Bei Jing
country: China
facility: Research Site
city: Bei Jing
country: China
facility: Research Site
city: Chang Chun
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Da Tong
country: China
facility: Research Site
city: Da Tong
country: China
facility: Research Site
city: Fen Yang
country: China
facility: Research Site
city: Guang Zhou
country: China
facility: Research Site
city: He Fei
country: China
facility: Research Site
city: Hong Kong
country: China
facility: Research Site
city: Ji Nan
country: China
facility: Research Site
city: Nan Ning
country: China
facility: Research Site
city: Qing Dao
country: China
facility: Research Site
city: Shan Tou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Tai Zhou
country: China
facility: Research Site
city: Tian Jin
country: China
facility: Research Site
city: Yin Chuan
country: China
facility: Research Site
Study officials:
References: