A confirmatory study of activity of immune checkpoint inhibitors for non-small cell lung cancer patients with interstitial pneumonia

A confirmatory study of activity of immune checkpoint inhibitors for non-small cell lung cancer patients with interstitial pneumonia - ICI Activity for NSCLC with IP

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030699

Enrollment

Registered

2018-03-01

Start date

2018-02-20

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 patients with interstitial pneumonia

Interventions

Immune checkpoint inhibitors

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Standard chemotherapy-resistant and relapsed non-small cell lung cancer patients 2) Patients with interstitial lung disease3) Age 20 years and over 4) ECOG performance status (PS) 0-2 5) No palliative radiotherapy for metastatic lesion within 14 days (local irradiation to brain metastatic lesion within 7 days) before registration 6) No grade 3 or higher superior vena cava syndrome, pericardial effusion, pleural effusion or ascites 7) With or without measurable lesions 8) Laboratory test at the start of treatment satisfies the following criteria: 1. WBC >= 3,000 /mm3 2. Neutrophil >= 1,000 /mm3 3. Hb >= 8.0 g/dL 4. Plt >= 7.5 x 10,000 /mm3 5. AST <= 100 IU/L 6. ALT <= 100 IU/L 7. T-Bil <= 1.5 mg/dL 8. Cr <= 1.2 mg/dL 9. SpO2 >= 90 % (room air) 9) Document consent has been obtained from the patient

Exclusion criteria

Exclusion criteria: 1) Systemic administration of steroids at 10 mg/day or more in terms of predonin 2) Active infection requiring systemic treatment 3) Fever of 38 degrees or more at axillary temperature at registration 4) Mental illness or psychiatric symptoms 5) Symptomatic brain metastases 6) Poor control hypertension 7) Continuous systemic administration of immunosuppressants 8) Poor control diabetes 9) Hypersensitivity to the drug 10) Pregnant women, lactating women, women who may be pregnant, or they are not willing to contraceptive 11) In addition, cases judged inappropriate by the attending physician

Design outcomes

Primary

Measure	Time frame
Exacerbation rate of interstitial lung diseases up to 6 months after initiation of immune checkpoint inhibitors	—

Secondary

Measure	Time frame
Overall response rate, Progression free survival, Overall survival, Adverse events, Risk factors developing exacerbation of interstial lung disease	—

Countries

Japan

Contacts

Public ContactTomoya Fukui

Kitasato University School of Medicine Department of Respiratory Medicine

tofukui@med.kitasato-u.ac.jp042-778-8111

Outcome results

None listed

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