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.

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Nivolumab; Drug: Pembrolizumab; Drug: Durvalumab; Drug: Tislelizumab; Drug: SYS6010; Drug: Enlonstobart; Drug: Toripalimab ±+platinum-based doublet chemotherapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 570
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 031169085587; Email: ctr-contact@cspc.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYS6010 + Enlonstobart	Drug: SYS6010; SYS6010; Drug: Enlonstobart; Enlonstobart; Other Names: SG001
Active Comparator: Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen	Drug: Nivolumab; Nivolumab; Other Names: Opdivo, BMS936558S; Drug: Pembrolizumab; Pembrolizumab; Other Names: KEYTRUDA® MK-3475; Drug: Durvalumab; Durvalumab; Other Names: MEDI4736; Drug: Tislelizumab; administered via Intravenous (IV) injection; Other Names: BGB-A317; Drug: Toripalimab ±+platinum-based doublet chemotherapy; Cisplatin; Carboplatin; Pemetrexed; Paclitaxel; Other Names: Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS was defined as the time from randomization to the date of death(whatever the cause).	Up to approximately 60 months
DFS assessed by investigators	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.	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
Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)		Approximately 13 months

Collaborators and Investigators

• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): November 30, 2031

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Platinum Compounds; Nivolumab; Pemetrexed; Carboplatin; Paclitaxel; Cisplatin; pembrolizumab; durvalumab; tislelizumab
• Other Study ID Numbers: SYS6010-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No