Phase II study of docetaxel, cisplatin, and zoledronic acid for advanced non-small cell lung cancer with bone metastases

Phase II study of docetaxel, cisplatin, and zoledronic acid for advanced non-small cell lung cancer with bone metastases - Phase II study of docetaxel, cisplatin, and zoledronic acid for NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000735

Enrollment

Registered

2007-06-07

Start date

2007-06-01

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 with bone metastases

Interventions

Zoledronic acid 4mg, day1 Docetaxel 60mg/m2, day1 Cisplatin 80mg/m2, day1 every 3 to 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically, or cytologically proven non-small cell lung cancer 2. Stage IV with bone metastases 3. No prior chemotherapy for cancer 4. Measurable or evaluable disease 5. Age 20-75 years old 6. Performance status of 0-1 7. Adequate organ functions 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Emergency of radiotherapy to bone metastases 2. No prior bisphosphonates for cancer 3. Uncontrolled pleural or pericardial effusion 4. Symptomatic brain metastasis 5. Active infection 6. Severe odontopathy 7. Interstitial pneumonia/active lung fibrosis on chest x-ray 8. Active concomitant malignancy 9. Pregnant or lactating women 10. Severe drug-allergy 11. Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding

Design outcomes

Primary

Measure	Time frame
feasibility	—

Secondary

Measure	Time frame
response rate, skeletal-related event, overall survival, adverse events	—

Countries

Japan

Contacts

Public ContactKiyotaka Yoh, MD

National Cancer Center Hospital East Thoracic Oncology Division

kyoh@east.ncc.go.jp04-7133-1111

Outcome results

None listed

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