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

Guangdong Association of Clinical Trials

Status: Unknown

Conditions: Small Cell Lung Cancer, Polygonal Type

Treatments: Other: No interventions will be taken in this Observational study

Study type: Observational

Funder types: Other

Identifiers

NCT03029858

ESR-16-12177 (Other Identifier)

CTONG1605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.