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A prospective observational study of pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities

A prospective observational study of pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities - Pembrolizumab and chemotherapy for lung cancer patients with interstitial abnormalities

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000038594
Enrollment
10
Registered
2019-11-21
Start date
2019-11-21
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

Interventions

None listed

Sponsors

Kobe University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients aged over 20 years old 2)Advanced or postoperative recurrence non-small cell lung cancer 3)Pembrolizumab plus platinum combination chemotherapy is planned as clinical practice. 4)The proportion of linear shadows, reticular abnormalities, or ground-glass abnormalities are less than 10% of all lung fields. 5) Written informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1)Patients with history of drug induced pneumonitis. 2)Patients who has increased infiltration other than lung cancer within 1 month. 3)Patients with interstitial pneumonitis with UIP pattern on computed tomography. 4)Patients with interstitial pneumonitis associated with collagen diseases. 5)Pregnant women and patients who may be pregnant or breastfeeding. 6)Patients who are judged to be inappropriate for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
The probability of pneumonitis in treatment of pembrolizumab plus platinum-based chemotherapy

Secondary

MeasureTime frame
1) Objective response rate 2) Disease control rate 3) Relapse free survival 4) Severity of pneumonitis 5) Provability of pneumonitis during observation period 6) Time to occurrence of pneumonitis 7) Probability of occurrence of adverse events

Countries

Japan

Contacts

Public ContactNaoko Katsurada

Kobe University Graduate School of Medicine Division of Respiratory Medicine, Department of Internal Medicine

nk1208@med.kobe-u.ac.jp81-78-382-5661

Outcome results

None listed

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