Small-cell Lung Cancer
Conditions
Brief summary
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).
Interventions
DRUGHLX07
HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
DRUGHLX10
HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
chemotherapeutics
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 2 years | Objective response rate by investigator assessment per RECIST 1.1 |
| PFS | Up to 2 years | Progression-free survival by investigator assessment per RECIST v1.1 |
Countries
China
Contacts
Primary ContactXuhui Hu, MD
Outcome results
None listed