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

Phase 1

• Conditions: on-small Cell Lung Cancer; MedDRA version: 16.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001662-42-GR
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-18
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Adult subjects with histologically or cytologically confirmed stage IV NSCLC who provide a tumor sample and are planned to receive 4-6 cycles of platinum-doublet based chemotherapy
• Radiographically evaluable disease according to modified RECIST 1.1 criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 97

Exclusion Criteria

• Known presence of epidermal growth factor receptor (EGFR) mutation
• Known brain metastases
• Prior therapy for the treatment of NSCLC, except if for non-metastatic disease and was completed at least 6 months prior to randomization
• Planned to receive bevacizumab
• 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
• Significant dental/oral disease, including prior history or current
evidence of osteonecrosis/ osteomyelitis of the jaw
• Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium, or vitamin D)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified