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

Non-squamous NSCLC Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04466917
• Other study ID #: 20180085
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 15, 2021
• Est. completion date: November 13, 2022

Study information

• Verified date: May 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 13, 2022
• Est. primary completion date: November 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer (NSCLC)
• Non-squamous NSCLC

Intervention

Drug:
• ABP 215
ABP 215 will be administered at a dose of 15 mg/kg IV
• Bevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg IV
• Paclitaxel
Paclitaxel will be administered 175 mg/m2 IV
• Carboplatin
Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Parexel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR).	From Day 1 to Week 19 (EOS)
Secondary	Progression-free survival (PFS)		From Day 1 to Week 19 (EOS)
Secondary	Duration of response (DOR)		From Day 1 to Week 19 (EOS)
Secondary	Maximum Plasma Concentration (Cmax)		Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Secondary	Area Under the Curve (AUC)		Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Secondary	Minimum observed concentration (Cmin)		Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Secondary	Number of participants with treatment-emergent adverse events		From Screening to Week 19 (EOS)
Secondary	Number of participants with treatment-emergent events of interest (EOIs)		From Screening to Week 19 (EOS)
Secondary	Number of participants with incidence of anti-drug antibodies (ADAs)		On Week 1, Week 7, Week 13 and Week 19 (EOS)

External Links

•   AmgenTrials clinical trials website