The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs.

The pilot study of nivolumab for advanced NSCLC patients with IIPs which is clinically considered to be at low risk of acute exacerbation of IIPs. - IP-NSCLC nivolumab study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022037

Enrollment

Registered

2016-04-24

Start date

2016-04-19

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

Advanced NSCLC patients with IIPs

Interventions

Nivolumab 3mg/kg, every 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Pathologically proven NSCLC 2)Subjects with IIPs which meets the criteria below I)VC is more than 80 percent of predicted II)Possible UIP or inconsistent UIP 3)Advanced stage 4)Second line or beyond 5)No IIPs worsening due to previous chemotherapy

Exclusion criteria

Exclusion criteria: 1)Subjects with the history of drug induced pneumonitis 2)Subjects with definite UIP pattern 3)Subjects with serious infection 4)Subjects with serious complications 5)Subjects with symptomatic brain metastases 6)Subjects with uncontrolled pleural effusion, ascites, and pericardial effusion

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Response rate, progression free survival	—

Countries

Japan

Contacts

Public ContactDaichi Fujimoto

Kobe city medical center general hospital Division of respiratory medicine

daichi@kcho.jp078-302-4321

Outcome results

None listed

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