Skip to content

A prospective study of efficacy and safety of atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia

A prospective study of efficacy and safety of atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia - Atezolizumab for patients with non-small cell lung cancer and interstitial pneumonia

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000034849
Enrollment
15
Registered
2018-11-12
Start date
2018-06-19
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

None listed

Sponsors

National Health Organization Kyoto Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pathologically confirmed the diagnosis of non-small cell lung cancer Advanced (unresectable) or recurrent after resection Refractory to one or more chemotherapeutic regimens and planned to be treated with atezolizumab A score of ECOG-PS is 0 to 2 The findings which are suspicious to interstitial pneumonia such as reticular opacity or fibrotic change are observed in two or more lobes of the lung confirmed by the CT performed within one month until the initiation of atezolizumab.

Exclusion criteria

Exclusion criteria: Severe renal dysfunction (eGFR < 30 ml/min/1.73m2) Severe liver dysfunction (AST > 100 IU/ml, ALT > 100 IU/ml, or T-Bil > 3 mg/dl) Respiratory failure (PaO2 < 60 mmHg or PaCO2 >45 mmHg on under room air atmosphere) Prior history of acute exacerbation of interstitial pneumonia or drug-induced pneumonitis Impossibility to obtain a written consent form Impossibility to obtain sufficient data of outcomes Judgement of unsuitability as a subject from researchers

Design outcomes

Primary

MeasureTime frame
Incidence of drug-induced pneumonitis during the initial and one month after the last administration of atezolizumab

Secondary

MeasureTime frame
Response rate and disease control rate of atezolizumab Progression-free and overall survival time from the initiation of atezolizumab Incidences of any adverse events from the initiation of atezolizumab

Countries

Japan

Contacts

Public ContactOsamu Kanai

National Health Organization Kyoto Medical Center Respiratory Medicine

geminus75@gmail.com075-641-9161

Outcome results

None listed

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