Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 25, 2021 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Amgen
- Interventions being studied
- Drug: Denosumab; Drug: Zoledronic acid; Drug: Placebo to Denosumab; Drug: Standard Chemotherapy; Drug: Placebo to Zoledronic Acid
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteGoodyear, Arizona
- Research SiteAnaheim, California
- Research SiteLong Beach, California
- Research SiteLos Angeles, California
- Research SiteLos Angeles, California
- Research SiteFarmington, Connecticut
- Research SiteAlexandria, Louisiana
- Research SiteBrewer, Maine
- Research SiteWestminster, Maryland
- Research SiteFairhaven, Massachusetts
- Research SiteDetroit, Michigan
- Research SiteEast Setauket, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 25, 2021. Always confirm current availability with the study team.