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

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.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer, Polygonal Type
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 155

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China
      • Fujian Principal Cancer Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of NanChang University
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China
      • Shanghai Chest Hospital Oncology dept.
    • Shanghai, Shanghai, China
      • Shanghai Chest Hospital Respiratory dept.
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • 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
    • Taizhou, Zhejiang, China
      • Zhejiang Taizhou Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure PD-L1 value	Measure PD-L1 value Change by tumor cells（TC）/immune cells(IC) staining from the baseline to progressive disease（PD）	baseline and PD，up to 24 months
Measure PD-L1 expression positive rate (%)	Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD）	baseline and PD，up to 24 months

Collaborators and Investigators

• Sponsor: Guangdong Association of Clinical Trials

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (ESTIMATE): January 24, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: CTONG1605; ESR-16-12177 (OTHER: Sponsor)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO