To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.
This study includes three stages: a neoadjuvant therapy stage, a surgery stage, and an adjuvant follow-up stage. In the neoadjuvant therapy stage, eligible participants will be stratified by stage (Stage II and Stage III) and mutation type (19Del and L858R) and randomized in a 1:1 ratio to the SYS6010 combined with osimertinib treatment group and the osimertinib monotherapy group. Neoadjuvant therapy will be administered for 3 cycles. In the surgery stage, the feasibility of surgery will be assessed by a thoracic surgery investigator. Surgery should be performed between Week 10 and Week 12 (i.e., D64-D84 after the first dose of neoadjuvant therapy). Tumor samples collected during surgery will be sent to a central pathology laboratory to assess pathological response. In the adjuvant therapy stage, all participants who undergo surgery will subsequently enter the adjuvant therapy stage. Participants who do not undergo surgery for reasons other than disease progression will also enter the adjuvant therapy stage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
SYS6010 by intravenous (IV) infusion
Osimertinib, oral
500 mg/m\^2 by IV infusion, Q3W
Major Pathological Response (MPR) Rate
Defined as the proportion of participants with ≤10% residual viable tumor cells in the resected primary tumor bed, as assessed by blinded independent pathological review (BIPR).
Time frame: Within 8 weeks post-surgery
Pathological Complete Response (pCR) Rate
The proportion of participants with no residual viable tumor cells in both the resected primary tumor bed and lymph nodes, as assessed by BIPR.
Time frame: Within 8 weeks post-surgery
Downstaging from N2 to N0/N1 or N1 to N0 at the time of surgery
Time frame: Within 8 weeks post-surgery
Disease-Free Survival (DFS)
Investigator-assessed DFS per RECIST v1.1
Time frame: Up to approximately 5.5 years after the last participant enrolled
Event-Free Survival (EFS)
Investigator-assessed DFS per RECIST v1.1
Time frame: Up to approximately 5.5 years after the last participant enrolled
Objective Response Rate (ORR)
Investigator-assessed ORR per RECIST v1.1
Time frame: Up to approximately 5.5 years after the last participant enrolled
Overall Survival (OS)
Time frame: Up to approximately 5.5 years after the last participant enrolled
Incidence of Adverse Events (AEs)
Time frame: Up to approximately 5.5 years after the last participant enrolled
Anti-drug Antibodies (ADAs) to SYS6010
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75 mg/m\^2 by IV infusion, Q3W
AUC 5 mg/mL•min by IV infusion, Q3W
Time frame: Up to approximately 5.5 years after the last participant enrolled