A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer

Shanghai Henlius Biotech20 enrolled

Overview

This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small-cell Lung Cancer

Interventions

HLX07DRUG

HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

HLX10DRUG

HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

carboplatin and etoposideDRUG

chemotherapeutics

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system) * No prior systemic therapy for ES-SCLC * Major organs are functioning well * Participant must keep contraception Exclusion Criteria: * Histologically or cytologically confirmed mixed SCLC * Known history of severe allergy to any monoclonal antibody * Known hypersensitivity to carboplatin or etoposide * Pregnant or breastfeeding females * Patients with a known history of psychotropic drug abuse or drug addiction * Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment

Locations (1)

Jilin Cancer Hospital

Changchun, Jilin, China

Outcomes

Primary Outcomes

ORR

Objective response rate by investigator assessment per RECIST 1.1

Time frame: up to 2 years

PFS

Progression-free survival by investigator assessment per RECIST v1.1

Time frame: Up to 2 years

Central Contacts

Xuhui Hu, MD

CONTACT

18618313742 Xuhui_Hu@henlius.com

Data from ClinicalTrials.gov

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