This is a randomized, open-label study of HLX10 plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: Arm A (HLX10): HLX10 + chemotherapy (carboplatin-etoposide) Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
To Evaluate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
A Randomized, Open-label Study of HLX10 Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Small cell lung cancer
All genders
18+
Recruiting now
Overview
Principal Investigator: Lori Pai, MD
Contact Us
Latoya Lashley
Study details
Inclusion Criteria
- 1. Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- 2. No prior systemic therapy for ES-SCLC.
- 3. Major organs are functioning well.
Exclusion Criteria
- 1. Histologically or cytologically confirmed mixed SCLC.
- 2. Known history of severe allergy to any monoclonal antibody.
- 3. Known hypersensitivity to carboplatin or etoposide.
Study Requirements
This study is divided into three stages: screening (28 days), treatment (until disease progression, intolerable toxicity, withdrawal, etc), and follow-up (including safety follow-up period and survival follow-up period). The study drugs including HLX10/ atezolizumab and chemotherapy drugs are administered every 3-week (21-day) cycle as follows: Investigational product: HLX10 or atezolizumab • HLX10, intravenous (IV) infusion, 300mg, administered on Day 1 of each 3-week (21 day) cycle. • Atezolizumab, intravenous (IV) infusion,1200mg, administered on Day 1 of each 3-week (21 day) cycle. Other study drugs: combined chemotherapy The following regimen will be given every 21-day (3-week) cycle for a maximum of 4 cycles. • Etoposide: 100 mg/m2, IV infusion, on Days 1, 2, and 3 of each cycle. • Carboplatin: Area under the concentration-time curve (AUC) = 5, IV infusion, on Day 1 of each cycle up to a dose of 750 mg. On Day 1, etoposide shall be administered following infusion of carboplatin.