This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups:
Test group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）
Age 18 ~ 75 (inclusive) years old, regardless of gender;
Patients with pathologically confirmed locally advanced or metastatic NSCLC, including: patients with stage IIIB or IIIC based on AJCC staging version 8 who are not suitable for surgical resection or radical chemoradiotherapy, or patients with stage IV NSCLC. For the dose escalation phase, patients must have EGFR-mutant locally advanced or metastatic NSCLC that has failed previous standard therapy, and for the dose selection phase and phase III study, patients must have EGFR-mutant locally advanced or metastatic NSCLC, which has not received EGFR-TKIs or other systemic therapy before. Patients who have received adjuvant/neoadjuvant chemotherapy may be included if disease progression occurred at least 6 months after completing treatment;
Carry at least one EGFR-sensitive mutation (ex19del or L858R, which can be combined with other EGFR mutations). EGFR mutation: Stage Ib: can be enrolled based on previous test results. Phase III: Take the test results of the central laboratory as the admission group;
At least one measurable lesion confirmed by CT or MRI, as defined by RECIST v1.1 criteria;
Patients with meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active CNS metastases;
History of other malignant tumors within 3 years prior to the first use of study drug, except for the following conditions: cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, or cervical carcinoma in situ, etc.;
Known allergies to SYS6010 or any ingredient of Osimertinib, or to humanized monoclonal antibodies;
Adverse events caused by prior anti-tumor therapy that have not resolved to ≤ Grade 1 (as per NCI-CTCAE v6.0), except for Grade 2 alopecia or peripheral neuropathy deemed by the investigator not to pose a safety risk;
Parallel
SYS6010
DrugSYS6010，intravenous injection
Osimertinib
DrugOsimertinib 80mg P.O. QD
platinum-pemetrexed
DrugPemetrexed (500 mg/m\^2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m\^2) every 3 weeks. Pemetrexed (500 mg/m\^2) plus cisplatin (75 mg/m\^2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by pemetrexed maintenance (500 mg/m\^2) every 3 weeks.
Progression Free Survival(PFS) evaluated by IRC
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Progression Free Survival(PFS) evaluated by investigator
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Overall survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Duration of Response (DOR)
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.
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