Small Cell Lung Cancer, Polygonal Type Clinical Trial
— ATHENEOfficial title:
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.
| Status | Not yet recruiting |
| Enrollment | 155 |
| Est. completion date | September 2020 |
| Est. primary completion date | September 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
| China | Fujian Principal Cancer Hospital | Fuzhou | Fujian |
| 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 | Hangzhou | Zhejiang |
| China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
| China | The first Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
| China | The second affiliated hospital of Nanchang University | Nanchang | Jiangxi |
| China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
| China | Shanghai Chest Hospital Oncology dept. | Shanghai | Shanghai |
| China | Shanghai Chest Hospital Respiratory dept. | Shanghai | Shanghai |
| China | Zhejiang Taizhou Hospital | Taizhou | Zhejiang |
| Lead Sponsor | Collaborator |
|---|---|
| Guangdong Association of Clinical Trials |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |