Efficacy of Osimertinib in Patients With Lung Cancer
1 other identifier
observational
100
1 country
1
Brief Summary
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 8, 2023
CompletedFirst Posted
Study publicly available on registry
December 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2025
CompletedDecember 18, 2023
December 1, 2023
4.5 years
December 8, 2023
December 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
progression-free survival
From registration onto that step until death, or censored at the date of last contact.
3 years
Overall survival
From registration onto that step until death, or censored at the date of last contact.
3 years
Eligibility Criteria
advanced or metastatic (stage IV) lung cancer
You may qualify if:
- Patients must be ≥18 years.
- Provision of fully informed consent prior to any study specific procedures.
- Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology.
- According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Cancer hospital
Changsha, Hunan, China
Biospecimen
needle biopsy for samples with DNA
Study Officials
- PRINCIPAL INVESTIGATOR
Yongchang Zhang, MD
Hunan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Deputy Director of Thoracic Oncology Department
Study Record Dates
First Submitted
December 8, 2023
First Posted
December 18, 2023
Study Start
January 1, 2021
Primary Completion
June 15, 2025
Study Completion
September 15, 2025
Last Updated
December 18, 2023
Record last verified: 2023-12