The LoPeZ study

Phase 2

Recruiting

• Conditions: Metastatic non-small cell lung carcinoma with bony metastases; Cancer - Lung - Non small cell; Cancer - Bone

• Registration Number: ACTRN12606000079549
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Signed informed consent 2.Histologically confirmed diagnosis of non-small cell lung carcinoma (NSCLC) – cytology alone is acceptable 3. Asymptomatic metastatic, previously unirradiated disease to the bone, detected by PET or PET/CT scan 4. Asymptomatic, assessable metastatic disease to previously unirradiated, non-osseous lesions detected by PET or PET/CT scan 5. ECOG performance status of 0-2. NB. Patients who are ECOG 2 must have a reduced PS due to comorbidities rather than their cancer 6. Estimated survival of at least 6 months 7. All potential patients, prior to registration must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists. 8. Women of child bearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study drug is ceased.

Exclusion Criteria

1. Surgery or chemotherapy within 4 weeks prior to registration onto the study2. Patient planned to start immediate treatment with systemic chemotherapy3. Patient planned to start immediate treatment with palliative radiotherapy to an index lesion, osseous or non-osseous.4. Patient previously received systemic treatment for metastatic non-small cell lung cancer. Prior adjuvant chemotherapy is allowed.5. Treatment with bisphosphonates within the last year6. Initial serum creatinine > 1.5 times the ULN and/or calculated creatinine clearance (by Cockroft-Gault Formula) <60 ml/min and/or known progressive renal disease.7. Corrected serum calcium concentration < 2.00 mmol/L8. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. 9. Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) 10. Another disease which could confound evaluation in this study11. Known hypersensitivity to zoledronic acid or other bisphosphonates12. Pregnancy or lactation13. Unlikely to cooperate fully during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the Visual metabolic response rate in asymptomatic non-osseous lesions[At 1 and 3 months, as determined by changes from baseline on [18F]-FDG PET/CT scans]

Secondary Outcome Measures

Name	Time	Method
The response of asymptomatic osseous metastases.[At 1 and 3 months, as determined by changes from baseline in [18F]-FDG PET/CT scans, according to visual criteria.];The response of asymptomatic non-osseous and osseous metastases.[At 1 and 3 months, as determined by changes from baseline in [18F]-FDG PET/CT scans, according to changes in standardised uptake value (SUV).];The objective response rate in asymptomatic non-osseous metastases, as determined by RECIST criteria.[];Risk and nature of skeletal related events[];Safety over the six months on study[];Overall and progression-free survival.[]