NCT04023812

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

25 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 30, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

4.6 years

First QC Date

May 30, 2019

Last Update Submit

February 14, 2025

Conditions

Keywords

prospectiveobservationalstage III NSCLC

Outcome Measures

Primary Outcomes (1)

  • To observe treatment patterns of unresectable, stage III NSCLC

    Treatment received before disease progress including chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy and radiotherapy

    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

    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

    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

    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

    Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stage III NSCLC patients who received no prior systemic therapy for NSCLC before study enrolment

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Research Site

Beijing, China, 100020, China

Location

Research Site

Beijing, China, 100044, China

Location

Research Site

Beijing, China, China

Location

Research Site

Datong, China, 030000, China

Location

Research Site

Datong, China, China

Location

Research Site

Fenyang, China, China

Location

Research Site

Guangzhou, China, China

Location

Research Site

Hefei, China, 330006, China

Location

Research Site

Jinan, China, 2501117, China

Location

Research Site

Nanning, China, 530021, China

Location

Research Site

Qingdao, China, China

Location

Research Site

Shantou, China, China

Location

Research Site

Taizhou, China, China

Location

Research Site

Tianjin, China, China

Location

Research Site

Yinchuan, China, 750004, China

Location

Research Site

Changchun, 130021, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Chengdu, 610042, China

Location

Research Site

Hong Kong, China

Location

Research Site

Shanghai, 200030, China

Location

Research Site

Shanghai, 200040, China

Location

Research Site

Shanghai, China

Location

Research Site

Shijiazhuang, 050011, China

Location

Research Site

Shijiazhuang, 063000, China

Location

Research Site

Shijiazhuang, 430079, China

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

May 30, 2019

First Posted

July 18, 2019

Study Start

July 16, 2019

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations