Status:
WITHDRAWN
A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
Lead Sponsor:
Amgen
Collaborating Sponsors:
Parexel
Conditions:
Metastatic Non-small Cell Lung Cancer (NSCLC)
Non-squamous NSCLC
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04466917
Start Date
May 15 2021
End Date
November 13 2022
Last Update
July 3 2023
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