The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia

The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia - The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021591

Enrollment

Registered

2016-04-01

Start date

2016-04-04

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

Advanced non-small cell lung cancer with idiopathic interstitial pneumonia

Interventions

carboplatin AUC6 D1 paclitaxel 200mg/m D1 tryweekly 4cycle nintedanib 150mg twice daily

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small-cell lung cancer 2) stage3B, stage4 or postoperative recurrence NSCLC 3) Idiopathic interstitial pneumonia 4) performance status 0 or 1 5) Age>=20 6) Measurable lesion 7) Adequate organ function WBC>=3000/mm3 and neutrophil count >=1500/mm3 Hgb>=9.0 g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<2.5*ULN ALT=<2.5*ULN, CRN=<1.5*ULN PaO2>=60.0 torr or SpO2>=93.0 % 8) Life expectancy > 8 weeks 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1)Uncotrollable angiona pectorias, cardian infarction, haear failure, diabetes mellitus, hypertension 2) Using prednisolone >10mg/day 3) Active infection 4) Active double cancers 5) symptomatic brain metastasis 6) Patients with uncontrolled pleural or pericardial effusion, or ascites 7) pregnancy 8) Patient with a history of allergy to CBDCA, PTX and nintedanib 9) Inappropriate patients in this study

Design outcomes

Primary

Measure	Time frame
The frequency of treatment-related ILD	—

Secondary

Measure	Time frame
RR: response rate OS: overall survival PFS: progression free survival	—

Countries

Japan

Contacts

Public ContactHisashi Tanaka

Hirosaki University Graduate School of Medicine Department of Respiratory Medicine

xyghx335@gmail.com+81-172-33-5111

Outcome results

None listed

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