Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer

Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3) as immunotherapy for patients with recurrent/metastatic lung cancer - Phase I trial of the Toll-like receptor 9 agonist CpG-ODN(K3)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023276

Enrollment

Registered

2016-09-01

Start date

2016-10-04

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

CpG-ODN(K3)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven lung cancer 2) Non-small cell lung cancer: Clinical stage III, IV, or postoperative recurrence Small cell lung cancer: Clinical stage II, III, IV 3) Age from 20 to 79 years 4) ECOG performance status of 0 or 1 5) Previously treated, one platinum doublet regimen 6) Response criteria of platinum doublet chemotherapy achieved more than and equal to SD A mesurable lesion is not required 7) Within 4 months after start of last cycle of platinum doublet chemotherapy 8) Recover from hematological toxicity 9) Adequate function of major organs 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous malignancies 2) Symptomatic brain metastasis 3) Massive pleural effusion required for tube drainage 4) Infectious disease requiring systemic treatment 5) Positive test for hepatitis B virus antigen or hepatitis C virus or human immunodeficiency virus 6) History of unstable angina or myocardial infarction 7) Interstitial pneumonia on chest CT 8) History of antiphospholipid antibody syndrome 9) Subjects with active, known or suspected autoimmune disease 10) Current use of aspirin, or anticlotting drug or thrombolytic agent 11) Receiving continuous systemic corticosteroid treatment 12) Pregnant status or lactation 13) Severe psychological disorder 14) Other ineligible status judged by medical oncologist

Design outcomes

Primary

Measure	Time frame
Assessment of safety	—

Secondary

Measure	Time frame
Progression-free survival Assessment of specific immune response Adverse event	—

Countries

Japan

Contacts

Public ContactSumiyuki Nishida

Osaka University Graduate School of Medicine Department of Respiratory Medicine and Clinical Immunology

sumiyuki-n@imed3.med.osaka-u.ac.jp06-6879-3831

Outcome results

None listed

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