A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)

NCT07672223 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SYS6010-015
• Study Type: interventional
• Target: 570
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS) assessed by the independent review committee (IRC)

  DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by IRC per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event.

  Up to approximately 60 months

Secondary Outcomes (6)

• Overall Survival (OS)

  Up to approximately 60 months

• DFS assessed by investigators

  Up to approximately 60 months

• Incidence and severity of Adverse Events (AEs)

  Approximately 15 months

• EORTC QLQ-30 questionnaire

  Approximately 13 months

• Blood concentration of SYS6010 and Enlonstobart

  Approximately 13 months

Study Arms (2)

SYS6010 + Enlonstobart

EXPERIMENTAL

Drug: SYS6010; Drug: Enlonstobart

Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen

ACTIVE COMPARATOR

Drug: Tislelizumab; Drug: Toripalimab ±+platinum-based doublet chemotherapy; Drug: Durvalumab; Drug: Pembrolizumab; Drug: Nivolumab

Interventions

SYS6010 DRUG

SYS6010

SYS6010 + Enlonstobart

Enlonstobart DRUG

Enlonstobart

Also known as: SG001

SYS6010 + Enlonstobart

Tislelizumab DRUG

administered via Intravenous (IV) injection

Also known as: BGB-A317

Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen

Toripalimab ±+platinum-based doublet chemotherapy DRUG

Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;

Also known as: Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;

Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen

Durvalumab DRUG

Durvalumab

Also known as: MEDI4736

Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen

Pembrolizumab DRUG

Pembrolizumab

Also known as: KEYTRUDA® MK-3475

Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen

Nivolumab DRUG

Nivolumab

Also known as: Opdivo, BMS936558S

Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and willingness to voluntarily provide written informed consent.
• Age 18 to 75 years, males or females.
• Histologically confirmed squamous or non-squamous NSCLC.
• Ability to provide qualified tumor samples.
• Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory.
• Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC).
• 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).

You may not qualify if:

• Participants with a condition requiring further surgical resection, in the investigator's opinion.
• Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.
• Eligible only for incomplete resection.
• Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.
• History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment.
• Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy.

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Cisplatin; Carboplatin; Pemetrexed; Paclitaxel; durvalumab; pembrolizumab; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open-label

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 26, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): November 30, 2031
• Last Updated: June 26, 2026

Record last verified: 2026-01