PD-L1 and Other Immuno-markers Influenced by Osimertinib... | NCT03029858

ID	Type	Description	Link
ESR-16-12177	Other Identifier	Sponsor

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Sep 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Jan 17, 2017

First Submission Date that Met QC Criteria

Jan 20, 2017

First Posted Date

Jan 24, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2017

Last Update Posted Date

Jan 24, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

155Estimated

Name	Type	Description	Arm Group Labels	Other Names
No interventions will be taken in this Observational study	Other	TAGRISSO(osimertinib/AZD9291）

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Shun Lu, M.D	Contact	86-13601813062		shun_lu@hotmail.com

Name	Affiliation	Role
Shun Lu, M.D	Shanghai Chest hospital of Shanghai Jiaotong University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Fujian Medical University Union Hospital		Fuzhou	Fujian		China
Fujian Principal Cancer Hospital

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).

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases