Clinical trial · Interventional
A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)
A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.
- 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)
The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Enlonstobart | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| SYS6010 | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| Toripalimab ±+platinum-based doublet chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SYS6010 + Enlonstobart
- interventionNames
- Drug: SYS6010
- Drug: Enlonstobart
- type
- ACTIVE_COMPARATOR
- label
- Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen
- interventionNames
- Drug: Tislelizumab
- Drug: Toripalimab ±+platinum-based doublet chemotherapy
- Drug: Durvalumab
- Drug: Pembrolizumab
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Disease-Free Survival (DFS) assessed by the independent review committee (IRC)
- timeFrame
- Up to approximately 60 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to understand and willingness to voluntarily provide written informed consent. 2. Age 18 to 75 years, males or females. 3. Histologically confirmed squamous or non-squamous NSCLC. 4. Ability to provide qualified tumor samples. 5. Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory. 6. Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC). 7. The International Association for the Study of Lung Cancer (IASLC) V9 Stage II-IIIB NSCLC, after confirmed complete surgical resection with resection margins proved microscopically free of disease (R0). Exclusion Criteria: 1. Participants with a condition requiring further surgical resection, in the investigator's opinion. 2. Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC. 3. Eligible only for incomplete resection. 4. Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC. 5. History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment. 6. Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available