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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT01951586

Run by

Amgen

People needed

226

Starts

2013-12-31

Expected to finish

2017-11-28

Last updated by the study team

2021-10-25

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Farmington, Connecticut, United States
• Research Site — Alexandria, Louisiana, United States
• Research Site — Brewer, Maine, United States
• Research Site — Westminster, Maryland, United States
• Research Site — Fairhaven, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — East Setauket, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Hickory, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Bismarck, North Dakota, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Kogarah, New South Wales, Australia
• Research Site — Wahroonga, New South Wales, Australia
• Research Site — Adelaide, South Australia, Australia
• Research Site — Footscray, Victoria, Australia
• Research Site — Parkville, Victoria, Australia
• Research Site — Wodonga, Victoria, Australia
• Research Site — Edmonton, Alberta, Canada
• Research Site — Goodyear, Arizona, United States

Full record on ClinicalTrials.gov

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