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

Amgen

Status and phase: Withdrawn; Phase 3

Conditions: Non-squamous NSCLC; Metastatic Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: Bevacizumab; Drug: Carboplatin; Drug: ABP 215; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04466917

20180085

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

ABP 215

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: ABP 215

Drug: Paclitaxel

Bevacizumab

Active Comparator group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Bevacizumab

Drug: Paclitaxel