Pembrolizumab as first-line therapy in poor performance status patients with advanced non-small-cell lung cancer highly expressing PD-L1: an open-label, single arm, multicenter, phase II study

Pembrolizumab as first-line therapy in poor performance status patients with advanced non-small-cell lung cancer highly expressing PD-L1: an open-label, single arm, multicenter, phase II study - Pembrolizumab in poor performance status patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030955

Enrollment

Registered

2018-04-01

Start date

2018-01-17

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

advanced non-small cell lung cancer

Interventions

treatment with pembrolizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) age of 20 years or older 2) histologically or cytologically proven non-small cell cancer 3) stage IV, incurable stage IIIB/C, or postoperative recurrent disease 4) treatment naive for lung cancer 5) PD-L1 (TPS = or > 50%) 6) without EGFR mutation or ALK fusion 7) without ROS1 fusion or unknown 8) an Eastern Cooperative Oncology Group performance status of 2 to 3 9) presence of a measurable lesion (RECIST ver. 1.1) 10) without uncontrolled severe comorbidities including pleural effusion, ascites and pericardial effusion, SVC symdrome, or spinal cord compression 11) without a history of palliative radiation therapy within 7 days of registration 12) adequate organ function 13) written informed consent

Exclusion criteria

Exclusion criteria: 1) comordity of auto-immune disease 2) history of organ transplantation 3) symptomatic brain metastasis (patients with stable condition for more than 7days after radiation will be allowed.) 4) carcinomatous meningitis 5) presence of other cancer within 2 years of registration 6) presence of severe comordity

Design outcomes

Primary

Measure	Time frame
objective response rate	—

Secondary

Measure	Time frame
progression free survival overall survival safety quality of life explore possible biomarkers	—

Countries

Japan

Contacts

Public ContactEiki Ichihara

Okayama University Hospital Allergy and respiratory medicine

ichiha-e@md.okayama-u.ac.jp086-235-7227

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026