A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

Phase 3

Withdrawn

• Conditions: Non-squamous NSCLC; Metastatic Non-small Cell Lung Cancer (NSCLC)
• Interventions: Drug: ABP 215; Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT04466917
• Lead Sponsor: Amgen

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.

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-10
• Status Verified: 2021-05
• Study Start: 2021-05-15
• Primary Completion: 2022-11-13
• Study Completion: 2022-11-13
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Paclitaxel	Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.
ABP 215	ABP 215	Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.
ABP 215	Paclitaxel	Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.
ABP 215	Carboplatin	Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles.
Bevacizumab	Bevacizumab	Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.
Bevacizumab	Carboplatin	Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants with incidence of anti-drug antibodies (ADAs)	On Week 1, Week 7, Week 13 and Week 19 (EOS)
Progression-free survival (PFS)	From Day 1 to Week 19 (EOS)
Duration of response (DOR)	From Day 1 to Week 19 (EOS)
Area Under the Curve (AUC)	Pre-dose on Week 1, Week 4, 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)
Number of participants with treatment-emergent adverse events	From Screening to Week 19 (EOS)
Maximum Plasma Concentration (Cmax)	Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Number of participants with treatment-emergent events of interest (EOIs)	From Screening to Week 19 (EOS)