Clinical trial NCT03029858: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Cell Lung Cancer, Polygonal Type
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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.

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.

Primary outcomes:
measure: Measure PD-L1 value
timeFrame: baseline and PD，up to 24 months
measure: Measure PD-L1 expression positive rate (%)
timeFrame: baseline and PD，up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Principal Cancer Hospital
state: Fujian
city: Nanchang
country: China
facility: The first Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The second affiliated hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital Oncology dept.
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital Respiratory dept.
state: Shanghai
city: Hangzhou
country: China
facility: The first Affiliated hospital of Zhejiang University, Thoracic Oncology Dept.
state: Zhejiang
city: Hangzhou
country: China
facility: The first Affiliated hospital of Zhejiang University，Respiratory dept.
state: Zhejiang
city: Hangzhou
country: China
facility: The second Affiliated hospital of Zhejiang University of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Zhejiang Taizhou Hospital
state: Zhejiang
Study officials:
affiliation: Shanghai Chest hospital of Shanghai Jiaotong University
name: Shun Lu, M.D
role: PRINCIPAL_INVESTIGATOR
References: