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PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients (ATHENE)

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ClinicalTrials.gov Identifier: NCT03029858
Recruitment Status : Not yet recruiting
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Guangdong Association of Clinical Trials

Brief Summary:
The study will investigate whether PD-L1 and other immuno-markers will be influenced by osimertinib treatment in advanced epidermal growth factor receptor (EGFR)T790M positive advanced NSCLC patients. In addition, we will 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.

Condition or disease Intervention/treatment
Small Cell Lung Cancer, Polygonal Type Other: No interventions will be taken in this Observational study

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.


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Study Type : Observational
Estimated Enrollment : 155 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Programmed Death-ligand 1(PD-L1) and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients
Study Start Date : January 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib


Intervention Details:
  • Other: No interventions will be taken in this Observational study
    TAGRISSO(osimertinib/AZD9291)


Primary Outcome Measures :
  1. Measure PD-L1 value [ Time Frame: baseline and PD,up to 24 months ]
    Measure PD-L1 value Change by tumor cells(TC)/immune cells(IC) staining from the baseline to progressive disease(PD)

  2. Measure PD-L1 expression positive rate (%) [ Time Frame: baseline and PD,up to 24 months ]
    Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease(PD)


Biospecimen Retention:   Samples With DNA

Tumor Formaldehyde Fixed-Paraffin Embedded (FFPE) tissue specimen collection • Tumor FFPE tissue specimen will be at least collected at baseline, disease progression and Response (optional) in sufficient amount (10 FFPE slices, thickness 4um, tumor cells≥25% and the area of necrotic tissues<10%).

Blood specimen collection(optional)

• The plasma specimen requirements for 10 ml blood will be collected at least at baseline, disease progression, and every 6 weeks, which is for detecting tumor mutation burden by QIAGEN Mix-561-Match Panel (561genes).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  1. The patient enrolled in ASTRIS or patient who are eligible for the ASTRIS study.
  2. The patient is willing to provide informed consent form to provide specimen before osimertinib treatment and at the time of PD.
  3. 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.
  4. Fine needle aspirate specimens are not acceptable.
  5. Specimens from metastatic bone lesions are typically unacceptable unless there is confirmed soft tissue component.
  6. 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:

  1. The patient does not have sufficient tumor tissue specimen available for detection.
  2. The Patient who is unwilling to use the existing data from medical practice for scientific research.
  3. The patient who received immunotherapy therapy before.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029858


Contacts
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Contact: Shun Lu, M.D 86-13601813062 shun_lu@hotmail.com

Locations
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China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Principal Cancer Hospital
Fuzhou, Fujian, China
China, Jiangxi
The first Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The second affiliated hospital of Nanchang University
Nanchang, Jiangxi, China
China, Shanghai
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China
Contact: Jianhua Chang         
Shanghai Chest Hospital Oncology dept. Not yet recruiting
Shanghai, Shanghai, China
Contact: Shun Lu    +86 13601813062    shun_lu@hotmail.com   
Shanghai Chest Hospital Respiratory dept. Not yet recruiting
Shanghai, Shanghai, China
Contact: Liyan Jiang         
China, Zhejiang
The first Affiliated hospital of Zhejiang University, Thoracic Oncology Dept.
Hangzhou, Zhejiang, China
The first Affiliated hospital of Zhejiang University,Respiratory dept.
Hangzhou, Zhejiang, China
The second Affiliated hospital of Zhejiang University of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Taizhou Hospital
Taizhou, Zhejiang, China
Sponsors and Collaborators
Guangdong Association of Clinical Trials
Investigators
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Principal Investigator: Shun Lu, M.D Shanghai Chest hospital of Shanghai Jiaotong University

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Responsible Party: Guangdong Association of Clinical Trials
ClinicalTrials.gov Identifier: NCT03029858     History of Changes
Other Study ID Numbers: CTONG1605
ESR-16-12177 ( Other Identifier: Sponsor )
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Osimertinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action