Back to Search Results
Study Complete
Sponsor ID
20120249

Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

Sponsor ID
20120249
Clinicaltrials.gov ID
NCT01951586
EUCTIS ID
N/A
EudraCT ID
2013-001662-42
Contact Us

Study Details

This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
226
Additional Study Details

Protocol Summary

Primary Outcome Measures

Relative benefit on overall survival (OS)

Timeframe: 36 months

Secondary Outcome Measures

Tumor Tissue RANK expression in correlation with overall survival

Timeframe: 36 months

Tumor tissue RANK expression in correlation with objective response rate (CR+PR) based on modified RECIST 1.1

Timeframe: 36 months

Tumor tissue RANKL expression in correlation with overall survival

Timeframe: 36 months

Tumor tissue RANKL expression in correlation with objective response (CR + PR) based on modified RECIST 1.1

Timeframe: 36 months

Objective response, clinical benefit rate & progression-free survival based on modified RECIST 1.1

Timeframe: 36 months

Serum denosumab trough levels

Timeframe: 36 months

Treatment-emergent adverse events

Timeframe: 36 months

Locations

Location
Status
Contact Us
Location
Research Site
Alexandria, LA, United States, 71301
Status
Recruiting
Location
Research Site
Anaheim, CA, United States, 92801
Status
Recruiting
Location
Research Site
Bismarck, ND, United States, 58501
Status
Completed
Location
Research Site
Goodyear, AZ, United States, 85338
Status
Recruiting
Location
Research Site
Hickory, NC, United States, 28602
Status
Recruiting
Location
Research Site
Long Beach, CA, United States, 90813
Status
Completed
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 100 Years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Dec 2013 - Jul 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Histologically or cytologically confirmed stage IV non-small cell lung carcinoma (NSCLC), according to 7th Tumor/Node/Metastasis (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 Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria - Other inclusion criteria may apply
    Exclusion Criteria:
    - Known presence of documented sensitizing epidermal growth factor receptor (EGFR) activating mutation or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation (screening following local standards, but strongly encouraged in non-squamous histology) - Known brain metastases (systematic screening of patients not mandatory) - Any prior systemic therapy (before randomization) 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 - Significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw, or with the following: ∙ Active dental or jaw condition which requires oral surgery ∙ Non-healed dental/oral surgery ∙ Planned invasive dental procedures for the course of the study.