To compare the efficacy and safety of 7MW3711 versus docetaxel in patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) .
All trial participants or their legally acceptable representatives must sign the Ethics Committee-approved informed consent form before any screening procedures are initiated.
Aged 18 to 85 years (inclusive) at the time of signing the informed consent, regardless of gender.
ECOG performance status of 0 to 1.
Histologically or cytologically confirmed unresectable locally advanced or metastatic squamous non-small cell lung cancer (NSCLC). Mixed pathology including small cell lung cancer or other pathological components must be excluded.
Received radiotherapy, chemotherapy, or other anti-tumor treatments within 21 days before the first dose; received anti-tumor traditional Chinese medicine within 7 days; received other investigational drugs or devices not yet on the market within 28 days; previously received antibody-drug conjugates (ADCs) or docetaxel.
Positive for clinically significant driver gene mutations, including EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET, RET, HER2.
Persistent clinically significant toxicities of Grade ≥ 2 related to prior therapy (excluding alopecia and Grade 2 immune-related endocrine toxicities requiring stable doses of replacement therapy).
Trial participants with clinically symptomatic effusions requiring local therapy or repeated drainage (pleural effusion, ascites, pericardial effusion, etc.).
Parallel
7MW3711
DrugParticipants will receive intravenous (IV) infusion of 7MW3711 as per protocol
Docetaxel
DrugParticipants will receive intravenous (IV) infusion of Docetaxel as per protocol
Overall Survival
Time from the date of randomization until the date of death from any cause.
Objective Response Rate per investigator
The percentage of subjects who experience a best response of either CR or PR.
Progression Free Survival per investigator
Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause.
Duration of Response per investigator
Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause.
Disease Control Rate per investigator
The percentage of subjects who experience a best response of CR, PR or stable disease (SD).
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