Clinical trial · Interventional
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
- 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 is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Esophageal Squamous Cell Carcinoma by AJCC V8 Stage | Esophageal Squamous Cell Carcinoma by AJCC v8 Stage | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy Doublet | Drug | — | UNRESOLVED |
| LBL-007 | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LBL-007
- description
- LBL-007 in combination with tislelizumab plus chemotherapy doublet.
- interventionNames
- Drug: LBL-007
- Drug: Tislelizumab
- Drug: Chemotherapy Doublet
- type
- ACTIVE_COMPARATOR
- label
- Tislelizumab and Chemotherapy
- description
- Tislelizumab plus chemotherapy doublet.
- interventionNames
- Drug: Tislelizumab
- Drug: Chemotherapy Doublet
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide written informed consent and can agree to comply with the study requirements. * Participants with metastatic ESCC or unresectable, locally advanced ESCC. * Histologically confirmed diagnosis of ESCC. * Can provide a tumor sample. * At least 1 measurable lesion as defined by RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. Exclusion Criteria: * Prior treatment for advanced or metastatic ESCC within the past 6 months * Locally advanced ESCC that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator * Palliative radiation treatment for ESCC within the past 4 weeks * Participants with an esophageal/bronchial or esophageal/aorta fistula * Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available