Clinical trial · Observational
PD-L1 and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced NSCLC Patients
Programmed Death-ligand 1(PD-L1) and Other Immuno-markers Influenced by Osimertinib Treatment in Advanced Non-small Cell Lung Cancer (NSCLC) Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer, Polygonal Type | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No interventions will be taken in this Observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Measure PD-L1 value
- timeFrame
- baseline and PD，up to 24 months
- description
- Measure PD-L1 value Change by tumor cells（TC）/immune cells(IC) staining from the baseline to progressive disease（PD）
- measure
- Measure PD-L1 expression positive rate (%)
- timeFrame
- baseline and PD，up to 24 months
- description
- Measure PD-L1 expression positive rate (%) change from the baseline to progressive disease（PD）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available