Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria: 1. Age equal to or more than 20 years at the time of consent. 2. Histologically or cytologically confirmed diagnosis of advanced or recurrent non-small cell lung cancer (NSCLC) with no prior systemic treatment. 3. Planned to receive first-line immune checkpoint blockade, including anti-PD-1/PD-L1 antibodies as monotherapy, in combination with chemotherapy, or in combination with anti-CTLA-4 antibodies. 4. Ability to provide written informed consent for participation in this study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Severe renal impairment (eGFR < 30 mL/min/1.73 m), including those undergoing hemodialysis. 2. Presence of active malignancies other than non-small cell lung cancer. 3. History of systemic therapy or radiotherapy for lung cancer or any other malignancy within the past 6 months (excluding palliative radiation for the non-small cell lung cancer being studied). 4. Prior treatment with immune checkpoint inhibitors. 5. Pregnant women or women who may be pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The association of the epigenetic clock and age acceleration with patients' baseline clinical condition prior to immune checkpoint blockade therapy, including Eastern Cooperative Oncology Group (ECOG) performance status, simplified comorbidity score, instrumental activities of daily living (IADL) scale, quality of life (QOL) assessments (EORTC QLQ-C30, EORTC QLQ-LC13, EQ-5D-5L), and cachexia-related biomarkers. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the association between the epigenetic clock and age acceleration and the efficacy of immune checkpoint blockade therapy, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), incidence of adverse events, and treatment discontinuation rate. Adverse events will be assessed using the worst grade observed during the entire treatment period based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with all treated patients included in the denominator. To assess changes in the epigenetic clock between baseline (prior to treatment) and 12 weeks after initiation of immune checkpoint inhibitor therapy. To evaluate the association between the epigenetic clock and biological age measured by BioAge. | — |
Countries
Japan
Contacts
Public ContactYusuke Inoue
Hamamatsu University School of Medicine Second Division, Department of Internal Medicine
Outcome results
None listed