Non-Squamous Non-Small Cell Lung Cancer MedDRA version: 17.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
OncoMed Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form 2. Histologically or cytologically confirmed Stage IV non-squamous non-small cell lung cancer 3. Availability of FFPE tumor tissue, either fresh core-needle-biopsied or archived 4. Age >= 21 years 5. ECOG performance status of 0 or 1 6. Disease that is measurable per RECIST v1.1 7. Adequate organ and marrow function 8. For women of childbearing potential, agreement to use two effective forms of contraception 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: 1. Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas 2. NSCLC with known EGFR mutation or anaplastic lymphoma kinase (ALK) gene translocation (such as EML4-ALK) 3. Prior or ongoing therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) for the treatment of Stage IV non-squamous non-small cell lung cancer 4. Evidence of tumor invading major blood vessels, cavitation of one or more pulmonary tumor mass(es) or tracheo-esophageal fistula 5. Brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease 6. Metastases involving the lumen of the gastrointestinal tract 7. Malignancies other than non-squamous non-small cell lung cancer successfully treated within 3 years prior to randomization (with the exception of certain early-stage cancers) 8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy 9. Significant intercurrent illness defined as an illness that may result in the subject´s death prior to their death from non-squamous non-small cell lung cancer and/or significantly limit their ability to comply with the requirements of this study 10. Recent hemoptysis >2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation 11. History of cerebral vascular accident (CVA) or transient ischemic attacks (TIAs) within 6 months of randomization 12. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study 13. Blood pressure (BP) of >140/90 mmH 14. History, signs or symptoms indicative of an increased cardiac risk, including, but not limited to BNP value of >100 pg/mL, left ventricular ejection fraction (LVEF) 3.0 m/s on Doppler echocardiogram, history of or current cardiac ischemia or congestive heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer;Secondary Objective: - To compare the safety of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To compare the rate of immunogenicity of Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To determine population pharmacokinetics of demcizumab when combined with carboplatin and pemetrexed in subjects with 1st-line stage IV non-squamous non-small cell lung cancer;Primary end point(s): To compare the Investigator-assessed median progression-free survival as assessed by RECIST v1.1 in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non squamous non-small cell lung cancer;Timepoint(s) of evaluation of this end point: At scheduled visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To compare the Investigator-assessed RECIST v1.1 response rate in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To compare the Investigator-assessed RECIST v1.1 clinical benefit rate (i.e., the rate of complete response + partial response + stable disease) in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To compare the Investigator-assessed progression-free survival at 6 months in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To compare the median survival in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To compare the Independent-Review-Facility-assessed RECIST v1.1 response rate and progression-free survival based solely on radiographs in Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To determine the half-life, volume of distribution and clearance of demcizumab when combined with carboplatin and pemetrexed in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To compare the safety profile through adverse events, monitoring, physical examination, vital signs, and clinical laboratory testing as outlined in the Schedule of Assessments between Arm 1 to Arm 2 and Arm 1 to Arm 3 in subjects with 1st-line stage IV non-squamous non-small cell lung cancer - To compare the incidence of anti-demcizumab antibody development and neutralizing antibody development in subjects with 1st-line stage IV non-squamous non-small cell lung cancer in Arm 1 to Arm 2 and Arm 1 to Arm 3;Timepoint(s) of evaluation of this end point: At scheduled visits. | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, New Zealand, Spain, United Kingdom
Contacts
Public ContactVP, Clinical Development
OncoMed Pharmaceuticals, Inc.
Outcome results
None listed