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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

Tracking Information
First Submitted Date January 17, 2017
First Posted Date January 24, 2017
Last Update Posted Date January 24, 2017
Study Start Date January 2017
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2017)
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients
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
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.
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 Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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).

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.

Condition Small Cell Lung Cancer, Polygonal Type
Intervention Other: No interventions will be taken in this Observational study
TAGRISSO(osimertinib/AZD9291)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 20, 2017)
155
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shun Lu, M.D 86-13601813062 shun_lu@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03029858
Other Study ID Numbers CTONG1605
ESR-16-12177 ( Other Identifier: Sponsor )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Guangdong Association of Clinical Trials
Study Sponsor Guangdong Association of Clinical Trials
Collaborators Not Provided
Investigators
Principal Investigator: Shun Lu, M.D Shanghai Chest hospital of Shanghai Jiaotong University
PRS Account Guangdong Association of Clinical Trials
Verification Date January 2017