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Not yet recruiting NCT07672223

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

Phase III Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SYS6010, Enlonstobart, Tislelizumab, Toripalimab ±+platinum-based doublet chemotherapy.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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).

Detailed description

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).

Interventions

  • Drug SYS6010
    SYS6010
  • Drug Enlonstobart
    Enlonstobart
  • Drug Tislelizumab
    administered via Intravenous (IV) injection
  • Drug Toripalimab ±+platinum-based doublet chemotherapy
    Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
  • Drug Durvalumab
    Durvalumab
  • Drug Pembrolizumab
    Pembrolizumab
  • Drug Nivolumab
    Nivolumab

Primary outcome measures

  • Disease-Free Survival (DFS) assessed by the independent review committee (IRC) [Time frame: Up to approximately 60 months]
Secondary outcome measures (6)
  • Overall Survival (OS) [Time frame: Up to approximately 60 months]
  • DFS assessed by investigators [Time frame: Up to approximately 60 months]
  • Incidence and severity of Adverse Events (AEs) [Time frame: Approximately 15 months]
  • EORTC QLQ-30 questionnaire [Time frame: Approximately 13 months]
  • Blood concentration of SYS6010 and Enlonstobart [Time frame: Approximately 13 months]
  • Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs) [Time frame: Approximately 13 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07672223 · SYS6010-015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗