A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis

A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis - A phase II clinical trial of denosumab treatment for advanced non-small cell lung cancer with bone metastasis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008314

Enrollment

Registered

2012-07-03

Start date

2012-07-01

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

Interventions

denosumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed NSCLC 2) Patients have radiologically apparent bone metastasis 3) Aged >=18 4) PS of 0-2 5) Adequate organ functions 6) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to denosumab 2) Need of emergency treatment for bone metastasis by radiotherapy or surgery 3) Need of treatment for hypercalcemia 4) Prior use of bisphosphonates 5) Symptomatic brain metastasis 6) Active severe infections 7) Severe odontopathy 8) Interstitial pneumonitis 9) Active concomitant malignancy 10) Pregnant or lactating 11) Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding, etc. 12) Problematic psychiatric disease 13) Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Incidence of skeletal-related events (SRE).	—

Secondary

Measure	Time frame
1) Time to develop SRE 2) Incidence of adverse events 3) Progression free survival 4) Overall survival 5) Response rate 6) Rate of change in bone metabolic markers 7) Rate of change in pain score	—

Countries

Japan

Outcome results

None listed

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