NCT04063163CompletedPhase 3
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Efficacy and Safety of HLX10 in Combination With Chemotherapy in Previously Untreated Patients With ES-SCLC
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 585 (actual)
- First submitted
- 17 Aug 2019
- Start date
- 12 Sept 2019
- Primary completion date
- 7 May 2024
- Lead sponsor
- Shanghai Henlius Biotech
- Diseases
- Lung cancer
- NCT number
- NCT04063163
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 585
- From 12 Sept 2019 to the primary completion date, 7 May 2024
- 5 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known history of severe allergy to any monoclonal antibody.
- Known hypersensitivity to carboplatin or etoposide.
- Patients with a known history of psychotropic drug abuse or drug addiction.
Other
- Histologically or cytologically confirmed mixed SCLC.
- Pregnant or breastfeeding females.
- Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Personalized Medicine Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Arkhangelsk Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Arkhangelsk | Russia | Unknown status |
| Komunalnyi zaklad Miska bahato Coordinator of this site? Confirm its status | Dnipropetrovsk | Ukraine | Unknown status |
| Medipol Mega Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.