This study was an open-label, multi-center, randomized phase III study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart versus Immunotherapy+ Platinum-based chemotherapy as First-Line treatment for patients with PD-L1-Positive locally advanced or metastatic NSCLC.
Aged 18-75 (inclusive) years old, male or females;
Participants with pathologically confirmed locally advanced or metastatic NSCLC. Including participants with stage IIIB or IIIC according to the 9th edition of AJCC staging who are not suitable for surgical resection or radical chemoradiotherapy, or participants with stage IV NSCLC
Participants who have not previously received systemic anti-tumor treatment. Those who have previously received adjuvant/neoadjuvant therapy will be allowed for inclusion if disease progression occurs 12 months after the end of treatment.
EGFR mutation negative and ALK fusion negative
Histology or cytology of the tumor confirms the presence of combined small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;
Participants with ROS1/RET/NTRK fusions, MET exon 14 skipping mutation, or BRAF V600E mutation.
Participants with meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;
Participants with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;
Parallel
SYS6010 injection
DrugSYS6010 is Lyophilized powder for injection as an EGFR-ADC. SYS6010 will be administered via intravenous infusion, Q3W, with 21 days as one treatment cycle, at a dose of 4.5 mg/kg.
Enlonstobart injection
DrugEnlonstobart is arecombinant human anti-PD-1 monoclonal antibody injection，and will be administered by intravenous infusion, Q3W, with 21 days as one treatment cycle at a dosage of 360 mg.
Tislelizumab injection
DrugTislelizumab is a marketed recombinant human anti-PD-1 monoclonal antibody injection, and will be administered by intravenous infusion, Q3W, with 21 days as one treatment cycle at a dosage of 200 mg.
Paclitaxel+Carboplatin or Pemetrexed + Cisplatin/Carboplatin
DrugPaclitaxel+Carboplatin or Pemetrexed + Cisplatin/Carboplatin are widely accepted and common chemotherapy medication. For squamous NSCLC, Paclitaxel+Carboplatin were recommended to be administrated on a 21-day cycle. For nonsquamous NSCLC, Pemetrexed + Cisplatin or Carboplatin were recommended to be administrated on a 21-day cycle.
Progression Free Survival (PFS) assessed by IRC
Overall survival (OS)
ORR assessed by investigators and IRC
DoR assessed by investigators and IRC
The Proportion of ADAanti-drug antibody positive of SYS6010 and Enlonstobart
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