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Terminated/Withdrawn
Sponsor ID
20180085

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

Sponsor ID
20180085
Clinicaltrials.gov ID
NCT04466917
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 3
Product
ABP 215
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
0
Additional Study Details

Protocol Summary

Primary Outcome Measures

Objective response rate (ORR)

Timeframe: From Day 1 to Week 19 (EOS)

Secondary Outcome Measures

Progression-free survival (PFS)

Timeframe: From Day 1 to Week 19 (EOS)

Duration of response (DOR)

Timeframe: From Day 1 to Week 19 (EOS)

Maximum Plasma Concentration (Cmax)

Timeframe: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)

Area Under the Curve (AUC)

Timeframe: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)

Minimum observed concentration (Cmin)

Timeframe: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)

Number of participants with treatment-emergent adverse events

Timeframe: From Screening to Week 19 (EOS)

Number of participants with treatment-emergent events of interest (EOIs)

Timeframe: From Screening to Week 19 (EOS)

Number of participants with incidence of anti-drug antibodies (ADAs)

Timeframe: On Week 1, Week 7, Week 13 and Week 19 (EOS)

Locations

No locations found.
Study Info
Age
N/A
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    N/A
    Trial Dates
    May 2021 - Nov 2022
    Inclusion and Exclusion 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.