Phase II study for efficacy and safety of pembrolizumab for chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer

Phase II study for efficacy and safety of pembrolizumab for chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer - Phase II study of first-line pembrilizumab for advanced NSCLC patients with poor PS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026259

Enrollment

Registered

2017-03-27

Start date

2017-06-01

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

lung cancer

Interventions

Pembroliaumab 200mg/body (day 1, q3 weeks) until clinical progression or unacceptable toxicities

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Definitively diagnosed with having previously untreated advanced non-small cell lung cancer by the specimens histologically or cytologically who have no indication for standard treatment of chemotherapy including cytotoxic chemotherapy and molecular targeted agents for driver mutation. Also, PD-L1 highly expressing NSCLC using PD-L1 IHC 22C3 pharmDx. 2) Age of 20 years and older 3) With adequate organ function of bone marrow reserve, liver, and kidney. (1) PS 3-4 (2) neutrophil count => 5,000/mm^3 (3) platelet => 50,000/mm^3 (4) hemoglobin => 8.0g/dL (5) AST/ALT < 5.0 times less than ULN (6) T.Bil <= 3.0mg/dL (7) serum creatinine <= 3.0mg/dL (8) ECG: without clinically problematic abnormalities (9) SpO2 more than 92% 4) With the status of below previous treatment at the time of beginning of chemotherapy. (1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation (2) Surgical procedure, including pleurodesis or pleural drainage * more than 8 weeks with lobectomy * more than 4 weeks without lobectomy, including exploratory thoracotomy * more than 2 weeks after completing procedure (pleurodesis or pleural drainage) 5) With written informed consent

Exclusion criteria

Exclusion criteria: 1) The age of less than 20 2) Indicative for cytotoxic chemotherapy or molecular targeted agents 3) Uncontrolled brain metastasis treated by palliative radiotherapy 4) Clinically active infection 5) Severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 6) Uncontrolled pleural effusion 7) Active other organ cancers 8) History of severe drug allergy 9) Uncontrolled digestive ulcer 10) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival, Overall survival, and Toxicity	—

Countries

Japan

Contacts

Public ContactYusuke Okuma

Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital Department of Respiratory Medicine and Thoracic Oncology

y-okuma@cick.jp03-3823-2101

Outcome results

None listed

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