Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease

Phase II study of Carboplatin plus nab-Paclitaxel for advanced non-small cell lung cancer patients with interstitial lung disease - Phase II study of CBDCA plus nab-PTX for advanced NSCLC patients with ILD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012989

Enrollment

Registered

2014-02-03

Start date

2014-06-10

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 interstitial lung disease

Interventions

4-6 cycles of chemotherapy with nab-Paclitaxl (100 mg/m2/day, day 1, 8, 15) and Carboplatin (AUC=6, day 1) repeated every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven non-small cell lung carcinoma 2) Clinical stage III, IV or recurrent disease after surgery 3) Diagnosed as interstitial lung disease 4) Severity of interstitial lung disease is mild or moderate 5) 20 years of age or older 6) ECOG performance status of 0 or 1 7) No prior chemotherapy for non-small cell lung cancer 8) No prior thoracic radiotherapy 9) With measurable or assessable lesions based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 10) No prior palliative radiotherapy for metastatic lesion within 14 days before registration 11) Adequate organ function 12) Estimated life expectancy of at least 12 weeks 13) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous active double malignancies 2) Other lung disease, including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vasucular disease 3) With symptomatic central nervous system metastases 4) Hypersensitvity to platinum or paclitaxel 5) Receiving systemic treatment with steroid or immunosuppressant 6) Positive for hepatitis B surface antigen 7) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the treatment period and lactating women. 8) Men who will not be compliant with a contraceptive regimen during and for the treatment period 9) Psychotic disorder which prevent the patient from giving informed consent 10) Other criteria judged by the investigator to make a patient unsuitable for the study

Design outcomes

Primary

Measure	Time frame
Exacerbation-free rate of ILD at 28 days after protocol treatment	—

Secondary

Measure	Time frame
Response rate, Progression-free survival, Overall survival, Exacerbation-free rate of ILD, Toxicities	—

Countries

Japan

Contacts

Public ContactHirotsugu Kenmotsu

Shizuoka Cancer Center Division of Thoracic Oncology

h.kenmotsu@scchr.jp055-989-5222

Outcome results

None listed

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