Non-small Cell Lung CancerPhase 3NCT07672223
A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)
A Phase 3 study testing SYS6010, Enlonstobart and Tislelizumab in people with Non-small Cell Lung Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- SYS6010, Enlonstobart and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2026to 30 Nov 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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).
Read the 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).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- SYS6010, Enlonstobart, Tislelizumab, Toripalimab ±+platinum-based doublet chemotherapy, Durvalumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010Drug
SYS6010
EnlonstobartDrug
Also called SG001
Enlonstobart
TislelizumabDrug
Also called BGB-A317
administered via Intravenous (IV) injection
Toripalimab ±+platinum-based doublet chemotherapyDrug
Also called Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
DurvalumabDrug
Also called MEDI4736
Durvalumab
PembrolizumabDrug
Also called KEYTRUDA® MK-3475
Pembrolizumab
NivolumabDrug
Also called Opdivo, BMS936558S
Nivolumab
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 + Enlonstobart | Experimental | Not described Receives: Drug: SYS6010; Drug: Enlonstobart |
| Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen | Active comparator | Not described Receives: Drug: Tislelizumab; Drug: Toripalimab ±+platinum-based doublet chemotherapy; Drug: Durvalumab; Drug: Pembrolizumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 60 months
Secondary outcomes (6)
Overall Survival (OS)
OS was defined as the time from randomization to the date of death(whatever the cause).
Measured: 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.
Measured: Up to approximately 60 months
Incidence and severity of Adverse Events (AEs)
Measured: Approximately 15 months
EORTC QLQ-30 questionnaire
Measured: Approximately 13 months
Blood concentration of SYS6010 and Enlonstobart
Measured: Approximately 13 months
Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Measured: Approximately 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672223
- Sponsor's protocol ID
- SYS6010-015
- Status last verified
- Jan 2026
- First submitted
- 21 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07672223
- Acronym / sponsor ID
- SYS6010-015
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYS6010SYS6010 | Drug | SYS6010 + Enlonstobart |
| EnlonstobartAlso: SG001Enlonstobart | Drug | SYS6010 + Enlonstobart |
| TislelizumabAlso: BGB-A317administered via Intravenous (IV) injection | Drug | Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen |
| Toripalimab ±+platinum-based doublet chemotherapyAlso: Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;Cisplatin; Carboplatin; Pemetrexed; Paclitaxel; | Drug | Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen |
| DurvalumabAlso: MEDI4736Durvalumab | Drug | Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen |
| PembrolizumabAlso: KEYTRUDA® MK-3475Pembrolizumab | Drug | Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen |
| NivolumabAlso: Opdivo, BMS936558SNivolumab | Drug | Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SYS6010, Enlonstobart and Tislelizumab in people with Non-small Cell Lung Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) assessed by the independent review committee (IRC) (time frame: Up to approximately 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.