UMIN-CTR Clinical Trial

Public title

Prospective observational study investigating the significance of the epigenetic clock in treatment-naive patients with non-small cell lung cancer receiving immune checkpoint blockade therapy

Acronym

EpiClock-NSCLC Study

Scientific Title

Prospective observational study investigating the significance of the epigenetic clock in treatment-naive patients with non-small cell lung cancer receiving immune checkpoint blockade therapy

Scientific Title:Acronym

EpiClock-NSCLC Study

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate the association between biological age assessed prior to immune checkpoint blockade therapy and treatment efficacy in patients with advanced non-small cell lung cancer. Additionally, the study will investigate the relationship between biological age, general condition, and quality of life (QOL), as well as changes in biological age induced by treatment.

Basic objectives2

Others

Basic objectives -Others

Not applicable.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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.

Key secondary outcomes

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

50

Name of lead principal investigator

1st name	Takafumi
Middle name
Last name	Suda

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

4313192

Address

1-20-1 Handayama, Chuo-ku, Hamamatsu, Japan

TEL

0534352263

Email

yinoue@hama-med.ac.jp

Name of contact person

1st name	Yusuke
Middle name
Last name	Inoue

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

4313192

Address

1-20-1 Handayama, Chuo-ku, Hamamatsu, Japan

TEL

0534352263

Homepage URL

Email

yinoue@hama-med.ac.jp

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name

Yusuke Inoue

Organization

Self-funding.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Chuo-ku, Hamamatsu, Japan

Tel

0534352680

Email

rinri@hama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

07

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

05

Month

20

Day

Date of IRB

Anticipated trial start date

2025

Year

07

Month

08

Day

Last follow-up date

2030

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patients with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC) who are scheduled to receive immune checkpoint inhibitor (ICI) monotherapy or combination therapy (with cytotoxic agents and/or anti-CTLA-4 antibodies) will be eligible for enrollment after providing written informed consent and meeting all inclusion criteria.
Whole blood samples will be collected either on the same day or within one week prior to the initial ICI administration. At this time, assessments will include quality of life (QOL), instrumental activities of daily living (IADL) scale, geriatric assessment using the G8 screening tool, and evaluation of cancer cachexia.
To calculate biological age (BioAge), blood test parameters including albumin, alkaline phosphatase, creatinine, C-reactive protein, HbA1c, and total cholesterol will be measured. Additionally, systolic blood pressure will be recorded the day before, the day of, and the morning after ICI administration.
A second blood sample for epigenetic clock analysis will be collected at 12 weeks after initiation of ICI therapy.
Blood samples collected at baseline and at week 12 will be stored in designated collection tubes and preserved at -80 degrees. In collaborating institutions, samples may be temporarily stored at -30 degrees and must be transferred in frozen condition to the Department of Internal Medicine II, Hamamatsu University School of Medicine within three months.

Registered date

2025

Year

05

Month

20

Day

Last modified on

2025

Year

07

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066204