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

Phase 2
Conditions
Advanced non-small cell lung cancer with interstitial lung disease
Registration Number
JPRN-UMIN000012989
Lead Sponsor
Kanagawa Cardiovascular and Respiratory Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
90
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Exacerbation-free rate of ILD at 28 days after protocol treatment
Secondary Outcome Measures
NameTimeMethod
Response rate, Progression-free survival, Overall survival, Exacerbation-free rate of ILD, Toxicities
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