NSCLCPhase 1SYS6010NCT07692048
A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC
A Phase 1 study testing SYS6010 in people with NSCLC, run by Sichuan University at 1 site in China.
Trial summary
Introduction: Patients with driver gene-negative non-small cell lung cancer (NSCLC) who experience treatment failure following immune checkpoint inhibitor (ICI) therapy have limited subsequent treatment options, representing an unmet clinical need. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- SYS6010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 31 Dec 2028
- Phase
- Phase 1
- 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
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.
- Have no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.
- Have experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:
- Progression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or
- Progression on platinum-based chemotherapy following prior anti-PD-(L)1 monotherapy (third-line); or
Show all 44Show fewer
- Progression on anti-PD-(L)1 monotherapy and considered unfit for platinum-based chemotherapy (second-line); or
- Progression on anti-PD-(L)1-containing therapy following prior platinum-based chemotherapy (third-line).
- Adjuvant or neoadjuvant therapy is counted as one prior line of therapy if the time between the last dose of chemotherapy and tumour recurrence is ≤ 6 months.
- Have at least one evaluable tumour lesion per RECIST v1.1 (see Appendix 1).
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).
- Have a life expectancy of ≥ 3 months as assessed by the investigator.
- Agree to undergo tumour tissue biopsy before the first study treatment and during the treatment period, whenever clinically feasible.
- Have adequate bone marrow, hepatic, renal, and coagulation function confirmed by laboratory tests obtained within 7 days before the first dose (transfusion or growth factor support is not permitted within 2 weeks prior to the screening assessment):
- Bone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; haemoglobin ≥ 90 g/L.
- Hepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN in the presence of liver metastases); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in the presence of liver metastases); albumin ≥ 28 g/L.
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula; see Appendix 3).
- Coagulation function: International normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Subjects with chronic hepatitis B virus (HBV) infection must have HBV-DNA < 1000 IU/mL and be willing to receive antiviral therapy throughout the study period.
- Toxicities from prior therapy must have recovered to ≤ Grade 1 (CTCAE v5.0) or to a stable condition per investigator assessment at the time of the first study dose (alopecia and pigmentation excepted).
- Subjects of childbearing potential must agree to use highly effective contraceptive methods (including vasectomy, abstinence, etc.; see Appendix 4) throughout the study period (from signing the ICF until 6 months after the last dose of investigational product).
- Subjects must be able to communicate well with the investigator and comply with protocol-required follow-up.
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.
- Have no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.
- Have experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:
- Progression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or
- Progression on platinum-based chemotherapy following prior anti-PD-(L)1 monotherapy (third-line); or
- Progression on anti-PD-(L)1 monotherapy and considered unfit for platinum-based chemotherapy (second-line); or
- Progression on anti-PD-(L)1-containing therapy following prior platinum-based chemotherapy (third-line).
- Adjuvant or neoadjuvant therapy is counted as one prior line of therapy if the time between the last dose of chemotherapy and tumour recurrence is ≤ 6 months.
- Have at least one evaluable tumour lesion per RECIST v1.1 (see Appendix 1).
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).
- Have a life expectancy of ≥ 3 months as assessed by the investigator.
- Agree to undergo tumour tissue biopsy before the first study treatment and during the treatment period, whenever clinically feasible.
- Have adequate bone marrow, hepatic, renal, and coagulation function confirmed by laboratory tests obtained within 7 days before the first dose (transfusion or growth factor support is not permitted within 2 weeks prior to the screening assessment):
- Bone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; haemoglobin ≥ 90 g/L.
- Hepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN in the presence of liver metastases); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in the presence of liver metastases); albumin ≥ 28 g/L.
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula; see Appendix 3).
- Coagulation function: International normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Subjects with chronic hepatitis B virus (HBV) infection must have HBV-DNA < 1000 IU/mL and be willing to receive antiviral therapy throughout the study period.
- Toxicities from prior therapy must have recovered to ≤ Grade 1 (CTCAE v5.0) or to a stable condition per investigator assessment at the time of the first study dose (alopecia and pigmentation excepted).
- Subjects of childbearing potential must agree to use highly effective contraceptive methods (including vasectomy, abstinence, etc.; see Appendix 4) throughout the study period (from signing the ICF until 6 months after the last dose of investigational product).
- Subjects must be able to communicate well with the investigator and comply with protocol-required follow-up.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Hospital, Sichuan University
Chengdu, Please Select, 610041
Benxia Zhang, PhD, 8602885421606, zhangbenxia1007@outlook.com
About this study
Introduction: Patients with driver gene-negative non-small cell lung cancer (NSCLC) who experience treatment failure following immune checkpoint inhibitor (ICI) therapy have limited subsequent treatment options, representing an unmet clinical need. EGFR is commonly expressed in EGFR wild-type NSCLC and represents a potential target for therapeutic intervention. Antibody-drug conjugates (ADCs) combine the high targeting specificity of antibodies with the potent cytotoxic effects of payloads. SYS6010 is an EGFR-targeting ADC conjugated to a topoisomerase I inhibitor. Preclinical and clinical studies suggest that the combination of ADCs and ICIs can synergistically enhance anti-tumor efficacy through multiple immunomodulatory mechanisms. Tislelizumab is an approved PD-1 inhibitor for advanced NSCLC. This study aims to evaluate the safety and efficacy of SYS6010 in combination with tislelizumab in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy.
Methods: This is an exploratory clinical trial enrolling patients with driver gene-negative NSCLC who have failed prior PD-1 or PD-L1 inhibitor therapy. The primary objective is to evaluate the safety of the combination therapy, with primary endpoints including the incidence, severity, and type of adverse events (AEs) according to NCI-CTCAE v6.0 criteria. Secondary objectives include assessing efficacy (objective response rate [ORR], disease control rate [DCR], duration of response [DOR], progression-free survival [PFS], overall survival [OS]) and exploring the association of potential predictive or prognostic biomarkers (e.g., EGFR and PD-L1 expression levels) with response to study treatment.
- Conditions
- NSCLC
- Being tested
- SYS6010
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010Drug
SYS6010 4.2mg/kg,Ivgtt，Q3W，plus Tislelizumab，200 mg，Ivgtt，Q3W
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC | Experimental | Not described Receives: Drug: SYS6010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse effect
Measured: From date of first administration up to approximately 3.5 years after the last patient is administrated
Secondary outcomes (5)
Objective Response Rate（ORR）
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.
Measured: Approximately 9-11 weeks after the first dose
Disease Control Rate（DCR）
It represents the total proportion of patients who achieved complete response (CR), partial response (PR), and disease stability (SD) after treatment, reflecting the overall control ability of the treatment on tumor growth.
Measured: From date of first administration up to approximately 3.5 years after the last patient is administrated
Duration of Response(DOR)
It refers to the period from when a patient starts receiving treatment until the tumor lesion shows an objective response (such as shrinking or disappearing) and then the disease progresses or recurs again.
Measured: From date of first administration up to approximately 3.5 years after the last patient is administrated
Progression-Free Survival(PFS)
Its definition is: the period from the start of randomization until tumor progression occurs objectively or until death due to any reason.
Measured: From date of first administration up to approximately 3.5 years after the last patient is administrated
Overall Survival (OS)
OS will be defined as the time from the date of first dosing until death due to any cause
Measured: From date of first administration up to approximately 5.5 years after the last patient is administrated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsheng Wang, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692048
- Sponsor's protocol ID
- SYS6010-2025-11-17-YSW
- Acronym
- SYS6010
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT07692048
- Acronym / sponsor ID
- SYS6010 / SYS6010-2025-11-17-YSW
- Conditions
- NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jul 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.
Introduction: Patients with driver gene-negative non-small cell lung cancer (NSCLC) who experience treatment failure following immune checkpoint inhibitor (ICI) therapy have limited subsequent treatment options, representing an unmet clinical need. EGFR is commonly expressed in EGFR wild-type NSCLC and represents a potential target for therapeutic intervention. Antibody-drug conjugates (ADCs) combine the high targeting specificity of antibodies with the potent cytotoxic effects of payloads. SYS6010 is an EGFR-targeting ADC conjugated to a topoisomerase I inhibitor. Preclinical and clinical studies suggest that the combination of ADCs and ICIs can synergistically enhance anti-tumor efficacy through multiple immunomodulatory mechanisms. Tislelizumab is an approved PD-1 inhibitor for advanced NSCLC. This study aims to evaluate the safety and efficacy of SYS6010 in combination with tislelizumab in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy.
Methods: This is an exploratory clinical trial enrolling patients with driver gene-negative NSCLC who have failed prior PD-1 or PD-L1 inhibitor therapy. The primary objective is to evaluate the safety of the combination therapy, with primary endpoints including the incidence, severity, and type of adverse events (AEs) according to NCI-CTCAE v6.0 criteria. Secondary objectives include assessing efficacy (objective response rate [ORR], disease control rate [DCR], duration of response [DOR], progression-free survival [PFS], overall survival [OS]) and exploring the association of potential predictive or prognostic biomarkers (e.g., EGFR and PD-L1 expression levels) with response to study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC | Experimental | Drug: SYS6010 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (44 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.
- Have no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.
- Have experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:
- Progression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or
Key exclusion criteria (0 listed)
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 4.2mg/kg,Ivgtt，Q3W，plus Tislelizumab，200 mg，Ivgtt，Q3W | Drug | Tislelizumab plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC |
Primary outcome
incidence of adverse effect
Time frame: From date of first administration up to approximately 3.5 years after the last patient is administrated
5 secondary outcomes
Objective Response Rate（ORR）
Time frame: Approximately 9-11 weeks after the first dose
Disease Control Rate（DCR）
Time frame: From date of first administration up to approximately 3.5 years after the last patient is administrated
Duration of Response(DOR)
Time frame: From date of first administration up to approximately 3.5 years after the last patient is administrated
Progression-Free Survival(PFS)
Time frame: From date of first administration up to approximately 3.5 years after the last patient is administrated
Overall Survival (OS)
Time frame: From date of first administration up to approximately 5.5 years after the last patient is administrated
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 9 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYS6010 in people with NSCLC, run by Sichuan University at 1 site in China.
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 44 inclusion and 0 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Benxia Zhang, PhD (86（028）85421606, zhangbenxia1007@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse effect (time frame: From date of first administration up to approximately 3.5 years after the last patient is administrated). 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 9 Jul 2026.