CSPC initiates phase 3 trial of SYS-6010 in combination with Enlonstobart in resected stage II–IIIB NSCLC

CAR-T Digest - August 2020

Weekly Digest - July 2026

30 June 2026: CSPC initiates phase 3 trial of SYS-6010 in combination with Enlonstobart in resected stage II–IIIB NSCLC

CSPC Pharmaceutical Group has initiated the phase 3 SYS6010-015 trial in China evaluating SYS6010, an EGFR-targeted antibody-drug conjugate, in combination with the PD-1 antibody Enlonstobart as adjuvant therapy for patients with completely resected stage II–IIIB NSCLC lacking actionable genomic alterations and who did not achieve major pathological response following prior treatment
The randomized, open-label, multicenter phase 3 study will compare SYS6010 plus Enlonstobart against standard PD-L1-based therapy, aiming to evaluate whether the ADC-immunotherapy combination can improve outcomes in a high-risk patient population that remains vulnerable to disease recurrence despite surgery and prior treatment
The trial targets a significant unmet need in resected NSCLC, where patients who fail to achieve MPR after neoadjuvant treatment generally face a higher risk of recurrence and limited post-surgical therapeutic options, underscoring the need for more effective adjuvant treatment strategies
SYS6010 is an EGFR-targeted ADC comprising a humanized anti-EGFR monoclonal antibody linked to a topoisomerase I inhibitor payload via a cleavable linker, enabling selective delivery of cytotoxic therapy to EGFR-expressing tumor cells. The ADC is being combined with Enlonstobart, a fully human anti-PD-1 monoclonal antibody, to potentially enhance anti-tumor activity through complementary mechanisms
Strategically, the initiation of this phase 3 trial expands CSPC’s ADC development efforts into earlier-stage lung cancer, advances the company’s ADC-immunotherapy combination strategy, and strengthens its position in the competitive EGFR-targeted oncology landscape as it seeks to establish SYS6010 across multiple treatment settings