PK/PD study of Pembrolizumab

Multicenter PK PD Study of Immune Checkpoint Inhibitors for Patients Aged 75 or Older with Advanced Non Small Cell Lung Cancer. - Elderly Pembro trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036606

Enrollment

100

Registered

2019-04-26

Start date

2019-03-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histlogically or cytologically confirmed EGFR mutation positive non small cell lung cancer(NSCLC) 2)Patients who are going to treat with Pembrolizumab monotherapy or combination therapy. 3)No object about organ function, prior treatment, performance status, or measurable lesion. 4)More than 75 years old 5)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients who have treated with Pembrolizumab 2)Patients who denied to collect sample 3)Patients whose attending doctor consider as inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of pembrolizumab	—

Secondary

Measure	Time frame
1)Responce rate 2)Disease control rate 3)Progression free survival 4)Overall survival 5)Adverse event 6)PK/PD/PGx 7)Biomarker	—

Countries

Japan

Contacts

Public ContactShigehiro Yagishita

National Cancer Center Research Institute Division of Molecular Pharmacology

syagishi@ncc.go.jp03-3542-2511

Outcome results