Phase 3
N=585
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
Extensive Stage Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04063163 ↗Enrolled (actual)
585
Serious AEs
37.1%
Results posted
Dec 2025
Primary outcome: Primary: OS — 15.77; 11.10 month — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HLX10 (Drug); carboplatin and etoposide (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shanghai Henlius Biotech
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY OS |
15.77; 11.10 | <0.001 sig |
| SECONDARY Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1 |
5.82; 4.34 | 0.001 sig |
| SECONDARY Objective Response Rate |
268; 115 | — |
| SECONDARY Duration of Response |
6.80; 4.17 | — |
Summary
This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer.
Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:
Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus < 65 years)
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04063163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.