A Randomized, Double-blind, Multi-center Phase 2 Trial of Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
- Conditions
- Metastatic lung cancer10038666
- Registration Number
- NL-OMON45036
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
- Histologically or cytologically confirmed stage IV non-small cell lung carcinoma
(NSCLC), according to 7th TNM classification (cytological specimens obtained by
bronchial washing or brushing, or fine-needle aspiration are acceptable)
- Subject has available and has provided consent to release to the sponsor (or
designee) a tumor block with confirmed tumor content (or approximately 20
unstained charged slides [a minimum of 7 slides is mandatory]) and the
corresponding pathology report
- Planned to receive 4 to 6 cycles of pemetrexed or gemcitabine in combination
with cisplatin or carboplatin
* For subjects to receive pemetrexed, planned to receive vitamin B12 and
folate per pemetrexed approved labeling
- Radiographically evaluable (measurable or non-measurable) disease (according
to modified RECIST 1.1 criteria, Appendix E)
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Male or female subjects * 18 years of age at the time of screening
- Adequate organ function, as defined by the following criteria:
*Serum aspartate aminotransferase (AST) * 2.5 x upper limit of normal (ULN)
(or AST * 5 x upper limit of normal (ULN) if liver metastases are present)
*Serum alanine aminotransferase (ALT) * 2.5 x ULN (or ALT * 5 x upper limit
of normal (ULN) if liver metastases are present)
*Serum total bilirubin (TBL) * 1.5 x ULN (or * 2.0 x upper limit of normal (ULN)
if liver metastases are present)
*Creatinine clearance * 45 mL/min (refer to section 6.3.1.3 for Cockcroft*Gault
formula)
- Serum calcium or albumin-adjusted serum calcium * 2.0 mmol/L
- Expected life expectancy of at least 3 months
- Subject has provided or subject*s legally acceptable representative has provided
informed consent prior to any study-specific activities/procedures being initiated
- Known presence of documented sensitizing epidermal growth factor receptor
(EGFR) activating mutation or EML4-ALK translocation (screening following local
standards, but strongly encouraged in non-squamous histology)
- Known brain metastases (systematic screening of patients not mandatory)
- Prior systemic therapy for the treatment of NSCLC (including chemoradiation),
except if for non-metastatic disease and was completed at least 6 months prior to
randomization
- Planned to receive bevacizumab
- Central (chest) radiation therapy within 28 days prior to randomization, radiation
therapy to any other site(s) within 14 days prior to randomization
- Prior administration of denosumab
- Subjects with sarcomatoid, carcinoid, and mesenchymal histologies
- More than 1 year of cumulative oral bisphosphonate usage prior to randomization
- More than 1 previous dose of IV bisphosphonate administration prior to
randomization
Please refer to pga 24 of the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To estimate the treatment effect of the combination of denosumab and standard<br /><br>of care (SOC) versus SOC alone on overall survival (OS).</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess whether any relative benefit on OS from the combination of denosumab<br /><br>and SOC versus SOC alone in NSCLC is associated with tumor RANK expression </p><br>