A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC

ConditionNSCLC

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSichuan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Inclusion Criteria

Trial design

Design model

Single group

Treatments tested in this trial

SYS6010
Drug
SYS6010 4.2mg/kg,Ivgtt，Q3W，plus Tislelizumab，200 mg，Ivgtt，Q3W

Treatment groups

21 Participants

are divided into 1 treatment group

Group A: Tislelizumab plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

incidence of adverse effect

Time frame

From date of first administration up to approximately 3.5 years after the last patient is administrated

Secondary outcomes

Objective Response Rate（ORR）

ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

From date of first administration up to approximately 3.5 years after the last patient is administrated

Other outcomes

EGFR protein expression

The correlation between EGFR protein expression and amplification level and the efficacy of ADC

Time frame

From date of first administration up to approximately 5.5 years after the last patient is administrated

PD-L1 protein expression

The correlation between PD-L1 protein expression and the efficacy of combined treatment, etc.

Time frame

From date of first administration up to approximately 5.5 years after the last patient is administrated

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: