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

• Conditions: Small Cell Lung Cancer, Polygonal Type

• Registration Number: NCT03029858
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-20
• Last Update Submitted: 2017-01-20
• Study First Posted: 2017-01-24
• Last Update Posted: 2017-01-24
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 155

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure PD-L1 value	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 (%)	baseline and PD，up to 24 months	Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD）

Trial Locations

Locations (12)

Fujian Principal Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, 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

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Taizhou Hospital; 🇨🇳 Taizhou, Zhejiang, China

The first Affiliated hospital of Zhejiang University, Thoracic Oncology Dept.; 🇨🇳 Hangzhou, Zhejiang, China

The first Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The second affiliated hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Shanghai Chest Hospital Respiratory dept.; 🇨🇳 Shanghai, Shanghai, China

Shanghai Chest Hospital Oncology dept.; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China