Clinical trial NCT04466917: A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
Official title: A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Metastatic Non-small Cell Lung Cancer (NSCLC)
Non-squamous NSCLC
Keywords: Biosimilar
Bevacizumab
Carboplatin
Paclitaxel
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2020-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria may apply.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: From Day 1 to Week 19 (EOS)
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From Day 1 to Week 19 (EOS)
measure: Duration of response (DOR)
timeFrame: From Day 1 to Week 19 (EOS)
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
measure: Area Under the Curve (AUC)
timeFrame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
measure: Minimum observed concentration (Cmin)
timeFrame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
measure: Number of participants with treatment-emergent adverse events
timeFrame: From Screening to Week 19 (EOS)
measure: Number of participants with treatment-emergent events of interest (EOIs)
timeFrame: From Screening to Week 19 (EOS)
measure: Number of participants with incidence of anti-drug antibodies (ADAs)
timeFrame: On Week 1, Week 7, Week 13 and Week 19 (EOS)
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: