Metastatic Non-small Cell Lung Cancer (NSCLC), Non-squamous NSCLC
Conditions
Keywords
Biosimilar, Bevacizumab, Carboplatin, Paclitaxel
Brief summary
The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).
Detailed description
Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. After randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.
Interventions
DRUGABP 215
ABP 215 will be administered at a dose of 15 mg/kg IV
DRUGBevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg IV
DRUGPaclitaxel
Paclitaxel will be administered 175 mg/m2 IV
DRUGCarboplatin
Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV
Sponsors
Parexel
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Subjects, Amgen, designated PAREXEL, and other clinical site staff will be blinded to the investigational product allocation for each subject.
Intervention model description
Subjects will be randomized to receive ABP 215 or bevacizumab on a 1:1 basis. All subjects will receive chemotherapy, following administration of investigational product.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed non-squamous NSCLC. * Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 and no more than 6 cycles of chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. * Other inclusion criteria may apply.
Exclusion criteria
* Small cell lung cancer (SCLC) or mixed SCLC and NSCLC. * Central nervous system (CNS) metastases. * Malignancy other than NSCLC. * Palliative radiotherapy for bone lesions inside the thorax. * Prior radiotherapy of bone marrow. * Active hepatitis B. * Active hepatitis C. * Tested positive for human immunodeficiency virus (HIV). * Life expectancy \< 6 months. * Woman of childbearing potential who is pregnant or is breast feeding. * Woman of childbearing potential who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment. * Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment. * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | From Day 1 to Week 19 (EOS) | The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR). |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) | From Day 1 to Week 19 (EOS) |
| Maximum Plasma Concentration (Cmax) | Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS) |
| Area Under the Curve (AUC) | Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS) |
| Progression-free survival (PFS) | From Day 1 to Week 19 (EOS) |
| Number of participants with treatment-emergent adverse events | From Screening to Week 19 (EOS) |
| Number of participants with treatment-emergent events of interest (EOIs) | From Screening to Week 19 (EOS) |
| Number of participants with incidence of anti-drug antibodies (ADAs) | On Week 1, Week 7, Week 13 and Week 19 (EOS) |
| Minimum observed concentration (Cmin) | Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS) |
Outcome results
None listed