About this trial
To evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
Eligibility criteria
Qualifiers
Aged 18-75 (inclusive) years old, male or females;
Patients with pathologically confirmed locally advanced or metastatic NSCLC, including those with stage IIIB or IIIC based on 8th edition of the AJCC staging system who are not suitable for surgical resection or radical chemoradiotherapy, or those with stage IV NSCLC. Patients with EGFR-mutated locally advanced or metastatic NSCLC who have failed EGFR TKI therapy,whereas patients progressed on first- or second-generation EGFR-TKIs must have also progressed on third-generation EGFR-TKIs if T790M mutation was detected as postive status.
Presence of at least one EGFR-sensitive mutation;
At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria;
Disqualifiers
Histologically or cytologically confirmed combined small cell lung cancer,squamous cell carcinoma, neuroendocrine carcinoma,or carcinosarcoma
Patients 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 randomization (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;
Patients with a history of other malignant tumors within 3 years prior to randomization, 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.;
Patients who are known to be allergic to any component of SYS6010 or to humanized monoclonal antibody products; allergic to carboplatin, cisplatin, or pemetrexed, or have contraindications for their use;
Trial design
Treatments tested in this trial
- SYS6010
- Pemetrexed
- Cisplatin
- Carboplatin