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NCT Number: NCT07672223

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

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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This is a randomized, open-label, multicenter, Phase III clinical study. Participants 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) will be enrolled and randomized in a 1:1 ratio to experimental (SYS6010 + Enlonstobart) or control (Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen) group. Random factors include disease stage (Stage II / IIIA vs. Stage IIIB), Pathological type (non-squamous cell carcinoma vs. squamous cell carcinoma), and lymph node status (positive vs. negative).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

SYS6010

Drug

SYS6010

Enlonstobart

Drug

Enlonstobart

Other names: SG001

Tislelizumab

Drug

administered via Intravenous (IV) injection

Other names: BGB-A317

Toripalimab ±+platinum-based doublet chemotherapy

Drug

Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;

Other names: Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;

Durvalumab

Drug

Durvalumab

Other names: MEDI4736

Pembrolizumab

Drug

Pembrolizumab

Other names: KEYTRUDA® MK-3475

Nivolumab

Drug

Nivolumab

Other names: Opdivo, BMS936558S

Primary outcomes

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

    Time frame: Up to approximately 60 months

    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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 60 months

    OS was defined as the time from randomization to the date of death(whatever the cause).

  2. DFS assessed by investigators

    Time frame: Up to approximately 60 months

    DFS was defined as the time from randomization to either the date of disease recurrence as assessed by investigators 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.

  3. Incidence and severity of Adverse Events (AEs)

    Time frame: Approximately 15 months

  4. EORTC QLQ-30 questionnaire

    Time frame: Approximately 13 months

  5. Blood concentration of SYS6010 and Enlonstobart

    Time frame: Approximately 13 months

  6. Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)

    Time frame: Approximately 13 months

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group officer

CONTACT

[email protected]

031169085587

Sponsors and collaborators

Lead sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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