Clinical trial · Interventional
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin and etoposide | Drug | — | UNRESOLVED |
| HLX07 | Drug | — | UNRESOLVED |
| HLX10 | Drug | Serplulimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HLX07+HLX10+Chemotherapy
- description
- HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
- interventionNames
- Drug: HLX07
- Drug: HLX10
- Drug: carboplatin and etoposide
Primary outcomes (2)
- measure
- ORR
- timeFrame
- up to 2 years
- description
- Objective response rate by investigator assessment per RECIST 1.1
- measure
- PFS
- timeFrame
- Up to 2 years
- description
- Progression-free survival by investigator assessment per RECIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available