Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706).

Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706). - Randomized trial of platinum based combination chemotherapy with or without Zoledronic acid as first line therapy for non-small cell lung cancer with bone metastases stratified by bone marker (TORG0706).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001916

Enrollment

160

Registered

2009-05-01

Start date

2008-10-01

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 carcinoma

Interventions

platinum based combination chemotherapy with Zoledronic acid platinum based combination chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically proven Non-small Cell Lung Cancer 2. At least 1 bone metastasis secondary to non-small cell lung cancer. 3. No prior chemotherapy. 4. More than 20 years of age 5. ECOG PS 0-2 6. Adequate organ function 7. Patients who have estimated life expectancy longer than 3 month 8. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Sever allergy 2. Required radiation or operation for bone metastases 3. Hypercalcemia 4. History of using bisphosphonate 5. Massive pleural effusion, ascites and pericardial effusion required drainage 6. Symptomatic brain metastasis 7. Patients with serious infections or suspected infections 8. Patients who need dental treatment 9. Active ineterstitial pneumonitis 10. Active concomitant malignancy 11. Pregnant or lactating women 12. Acute Myocardial Infarction within 6 months. 13. Patinets with uncontroled complications 14. Psychological symptoms not suitable for this study 15. other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Time to first SRE(Skeletal Related Events)	—

Secondary

Measure	Time frame
SRE rate Adverse events Overall survival Progression free survival Treatment completion proportion Response rate Bone markers Pain score	—

Countries

Japan

Contacts

Public ContactYukio Hosomi

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Division of Pulmonary Medicine

yhosomi@cick.jp03-3823-2101

Outcome results

None listed

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