To evaluate the efficacy and safety of TQB6411 for injection in trial participant with advanced lung cancer
Participants voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance;
Age between 18 and 75 years (calculated based on the date of signing the informed consent form);
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
Expected survival greater than 12 weeks;
History of or concurrent other malignancies, except for: other malignancies treated with surgery alone and achieving ≥5 years of disease-free survival (DFS); or cured carcinoma in situ of cervix, non-melanoma skin cancer, or superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading basement membrane)].
Diseases affecting intravenous injection or blood sampling.
Adverse reactions from prior therapies not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 grade ≤1, except for: grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant asymptomatic grade 2 laboratory abnormalities, hypothyroidism stabilized with hormone replacement, or other toxicities judged by investigator as non-safety risks.
Major surgery (Grade 3 or above per National Surgical Classification Catalog 2022), significant traumatic injury within 4 weeks prior to first dose, planned major surgery during study (except protocol-specified procedures), or presence of unhealed wounds/fractures.
Single group
TQB6411 for Injection
DrugTQB6411 for Injection is administered every 21 days as a treatment cycle. TQB6411 for injection is administered every 28 days as a treatment cycle.
Recommended Phase II Dosage for the Treatment (RP2D)
Recommended phase II dosage for the treatment of advanced Lung Cancer.
Objective Response Rate (ORR)
Objective response rate for the treatment of advanced Lung Cancer.
Disease Control Rate (DCR)
Disease control rate for the treatment of advanced Lung Cancer.
Duration of Relief (DOR)
Duration of relief for the treatment of advanced Lung Cancer.
Progression-Free Survival
Progression-free survival for the treatment of advanced Lung Cancer.
Overall Survival (OS)
Overall survival for the treatment of advanced Lung Cancer.
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