- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03029858
PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients (ATHENE)
Programmed Death-ligand 1(PD-L1) and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced EGFR T790M positive advanced NSCLC patients.
explore whether PD-L1 and other immuno-markers can predict the safety and efficacy of subsequent use of immune checkpoint inhibitors at the time of PD due to osimertinib resistance.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Fujian
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Fuzhou, Fujian, China
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, China
- Fujian Principal Cancer Hospital
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Jiangxi
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Nanchang, Jiangxi, China
- The Second Affiliated Hospital of Nanchang University
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Nanchang, Jiangxi, China
- The First Affiliated Hospital of Nanchang University
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Shanghai
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Shanghai, Shanghai, China
- Fudan University Shanghai Cancer Center
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Shanghai, Shanghai, China
- Shanghai Chest Hospital Oncology dept.
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Shanghai, Shanghai, China
- Shanghai Chest Hospital Respiratory dept.
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Zhejiang
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Hangzhou, Zhejiang, China
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, China
- The first Affiliated hospital of Zhejiang University, Thoracic Oncology Dept.
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Hangzhou, Zhejiang, China
- The first Affiliated hospital of Zhejiang University,Respiratory dept.
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Hangzhou, Zhejiang, China
- The Second Affiliated Hospital of Zhejiang University of Medicine
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Taizhou, Zhejiang, China
- Zhejiang Taizhou Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Adult patients (≥18 years old) with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC with confirmed T790M mutation, who have received prior EGFR-TKI therapy,These patients are those who were enrolled in ASTRIS(Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC) or patients who were eligible for the ASTRIS study.
The study is a post observational study for ASTRIS study,and the patients would not take Osimertinib in this study any more.
Description
Inclusion Criteria:
- The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study.
- The patient is willing to provide informed consent form to provide specimen before osimertinib treatment and at the time of PD.
- Patients must be able to undergo a fresh tumor biopsy during screening or to provide an available tumor sample taken <2 months prior to screening.
- Fine needle aspirate specimens are not acceptable.
- Specimens from metastatic bone lesions are typically unacceptable unless there is confirmed soft tissue component.
- The tumor specimen submitted to establish eligibility should be of sufficient quantity to allow for PD-L1 IHC and other biomarker analyses (if applicable) and is preferred in formalin-fixed paraffin embedded blocks.
Exclusion Criteria:
- The patient does not have sufficient tumor tissue specimen available for detection.
- The Patient who is unwilling to use the existing data from medical practice for scientific research.
- The patient who received immunotherapy therapy before.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure PD-L1 value
Time Frame: baseline and PD,up to 24 months
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Measure PD-L1 value Change by tumor cells(TC)/immune cells(IC) staining from the baseline to progressive disease(PD)
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baseline and PD,up to 24 months
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Measure PD-L1 expression positive rate (%)
Time Frame: baseline and PD,up to 24 months
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Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease(PD)
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baseline and PD,up to 24 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTONG1605
- ESR-16-12177 (OTHER: Sponsor)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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