A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

To evaluate the efficacy and safety of TQB6411 for Injection in subjects with advanced lung cancer

Eligibility criteria

Qualifiers

Subjects 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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • TQB6411 for Injection

Treatment groups

465 Participants
are divided into 1 treatment group