> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-on-the-efficacy-and-safety-of-tqb6411-for-eaebe901-8867-4cdd-8d27-25a8bb655b12 > Record changed: 2026-10-13 # A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection NCT07367529 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) Participants 465 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) Lead sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) Start date 2026-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) Number of sites 38 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Title and summary **Summary** To evaluate the efficacy and safety of TQB6411 for Injection in subjects with advanced lung cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Short title** A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Official title** A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB6411 for Injection in Patients With Advanced Lung Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **First posted** 2026-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Registry last updated** 2026-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Start date** 2026-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Size and sites **Participants** 465 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Planned participants** 465 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Number of sites** 38 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Lead sponsor** Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Identifiers **Registry ID** NCT07367529 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **ClinicalTrials.gov ID** NCT07367529 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Outcomes ### Primary outcomes 1. Recommended Phase II Dosage for the Treatment (RP2D) Timeframe: Baseline up to 21 days Recommended phase II dosage for the treatment of advanced Lung Cancer. 2. Objective Response Rate (ORR) Timeframe: Baseline up to 6 mouths Objective response rate for the treatment of advanced Lung Cancer. ### Secondary outcomes 1. Disease Control Rate (DCR) Timeframe: Baseline up to 6 mouths Disease control rate for the treatment of advanced Lung Cancer. 2. Duration of Relief (DOR) Timeframe: Baseline up to 2 years Duration of relief for the treatment of advanced Lung Cancer. 3. Progression-Free Survival Timeframe: Baseline up to 2 years Progression-free survival for the treatment of advanced Lung Cancer. 4. Overall Survival (OS) Timeframe: Baseline up to 3 years Overall survival for the treatment of advanced Lung Cancer. 5. Adverse Events (AE) Timeframe: Baseline up to 2 years Numbers of participant with incidence and severity of adverse events, serious adverse events, and adverse events associated with investigational drugs (including investigational drugs and control drugs), as well as abnormal laboratory indicators were evaluated. 6. Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb) Timeframe: Cycle 1 day 1, Cycle 4 day 1, Cycle 6 day 1, Cycle 12 daye 1: 60 minutes before administration (21 days as a treatment cycle) Immunogenicity in patients with advanced lung cancer, Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (NAb). 7. Peak concentration (Cmax) Timeframe: Before administration, 30 minuets, 15 minuets after administration The plasma concentration at which the rate of administration and rate of elimination are in equilibrium. 8. Plasma concentration at steady state (Cav, SS) Timeframe: Pre-dose of day 1 on multiple dose and 2, 6, 24, 72 hours, 7, 14 days post-dose on multiple dose of day 1 The plasma concentration at which the rate of administration and rate of elimination are in equilibrium. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria - 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; - At least one measurable lesion according to RECIST v1.1 criteria; - Laboratory test results meeting the following criteria (no blood transfusion within 14 days or hematopoietic growth factor administration within 7 days prior to screening): 1. Hemoglobin (HGB) ≥ 90 g/L; 2. Absolute neutrophil count (NEUT) ≥ 1.5×10⁹/L; 3. Platelet count (PLT) ≥ 90×10⁹/L; 4. Total bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN); 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 5×ULN if liver metastases are present); 6. Serum creatinine (CR) ≤ 1.3×ULN or creatinine clearance rate (CCR) ≥ 50 mL/min; 7. Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy within the past 2 weeks); - Lung cancer confirmed by histology or cytology； - Willing to provide qualified tumor tissue samples for immunohistochemical testing and amplification, unless the subject has no eligible archived specimens and is unsuitable or refuses re-biopsy; - Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with a negative serum or urine pregnancy test within 7 days before enrollment; male subjects must agree to use effective contraception during the study and for 6 months after study completion (see Section 5.5 for details). ### Exclusion criteria - 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. - Any bleeding or hemorrhagic events ≥CTCAE grade 3 within 4 weeks prior to first dose. - Arterial/venous thromboembolic events within 6 months prior to first dose, including: cerebrovascular accidents (including transient ischemic attack (TIA), excluding lacunar infarction), deep vein thrombosis, or pulmonary embolism (implantable venous port- or catheter-related thrombosis or superficial venous thrombosis not considered "severe" thromboembolism). - Active viral hepatitis with poor control, except: hepatitis B surface antigen (HBsAg)-positive subjects with Hepatitis B virus Deoxyribonucleic acid (HBV DNA) <500 IU/mL (2500 copies/mL) who agree to receive anti-HBV therapy throughout study; or hepatitis C virus (HCV)-infected subjects (Hepatitis C Virus Antibody or Ribonucleic Acid positive) with hepatitis C virus Ribonucleic Acid (HCV RNA) ≤ULN continuing approved antiviral therapy. - Active syphilis requiring treatment. - Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced/radiation pneumonitis requiring treatment, clinically significant active pneumonia, history of interstitial lung disease (ILD) requiring treatment, or current ILD. - History of psychotropic drug abuse or mental disorders. - Prior or planned allogeneic bone marrow or solid organ transplantation. - History of hepatic encephalopathy. - Significant cardiovascular diseases including: 1. Cardiac dysfunction ≥New York Heart Association (NYHA) class II or Left Ventricular Ejection Fractions (LVEF) <50% by echocardiography; 2. Clinically significant ventricular arrhythmia history (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmias requiring continuous antiarrhythmic therapy (subjects with stable atrial fibrillation controlled solely by β-blockers may be included after investigator assessment); 3. Unstable angina; 4. Myocardial infarction within 12 months; 5. Cardio contraction time (QTc) >450ms (male) or >470ms (female) (if abnormal, measure three times at ≥2-minute intervals and average; corrected by Fridericia or Bazett method); 6. Congenital long QT syndrome or family history. - Active or uncontrolled severe infection (≥CTCAE grade 2). - Renal failure requiring hemodialysis or peritoneal dialysis. - Immunodeficiency including HIV positivity or other acquired/congenital immunodeficiency diseases. - Uncontrolled autoimmune diseases requiring immunosuppressants or systemic corticosteroids (>10mg prednisone/day equivalent) within 7 days prior to first dose. - Epilepsy requiring treatment. - Poorly controlled diabetes (fasting blood glucose >10mmol/L). - Tumor-related conditions and treatments: 1. Chemotherapy, immunotherapy, or small-molecule targeted therapy within 3 weeks prior to first dose or within 5 half-lives (whichever shorter); prior local radiotherapy allowed if: completed >4 weeks (>2 weeks for brain) before study treatment, and target lesions are outside radiation field or show progression within field; 2. National Medical Products Administration (NMPA)-approved traditional Chinese medicines with antitumor indications within 1 week prior to first dose; 3. Tumor invading major vessels or judged likely to cause fatal hemorrhage; 4. Uncontrolled effusions/ascites requiring recurrent drainage; 5. Spinal cord compression, leptomeningeal metastases, or brain metastases with symptoms controlled <4 weeks, or requiring steroids/dehydrating agents within 2 weeks before treatment. - Known hypersensitivity to study drug or excipients. - Prior treatment with: Epidermal Growth Factor Receptor/cellular-mesenchymal epithelial transition factor (EGFR/c-Met)-targeted antibody-drug conjugates (ADCs); or topoisomerase I inhibitors (Non-Small Cell Lung Cancer only) or topoisomerase I inhibitor-based ADCs. - Prior EGFR/c-Met-targeted Monoclonal Antibody (mAbs)/bispecifics with: ≥grade 4 toxicity, permanent discontinuation due to toxicity, ≥grade 3 infusion reactions, or ≥grade 3 myalgia. - Participation in other antitumor clinical trials within 4 weeks prior to first dose. - Other conditions judged by investigator to jeopardize subject safety or study completion. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Sites - Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaRecruiting - Beijing Chest Hospital，Capital Medical UniversityBeijing, ChinaNot yet recruiting - Chongqing University Affiliated Three Gorges HospitalChongqing, ChinaNot yet recruiting - The first affiliated hospital of Guangzhou medical universityGuangzhou, ChinaNot yet recruiting - The first affiliated hospital of Guangzhou medical universityGuanzhou, ChinaNot yet recruiting - Zhongshan City People's HospitalZhongshan, ChinaNot yet recruiting - Guangxi Medical University Cancer HospitalNanning, ChinaNot yet recruiting - Guangxi Medical University Cancer HospitalNanning, ChinaNot yet recruiting - Cangzhou Central hospitalCangzhou, ChinaNot yet recruiting - Cangzhou Central hospitalCangzhou, ChinaNot yet recruiting - Harbin Medical University Cancer HospitalHarbin, ChinaNot yet recruiting - Harbin Medical University Cancer HospitalHarbin, ChinaNot yet recruiting - Anyang People's HospitalAnyang, ChinaNot yet recruiting - Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)Luoyang, ChinaNot yet recruiting - Nanyang Second General HospitalNanyang, ChinaNot yet recruiting - Zhongnan Hospital of Wuhan UniversityWuhan, ChinaNot yet recruiting - The Third Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting - Jiangsu Provincial Hospital of Traditional Chinese MedicineNanjin, ChinaNot yet recruiting - Nanjing Drum Tower HospitalNanjing, ChinaNot yet recruiting - Northern Jiangsu People's HospitalYangzhou, ChinaNot yet recruiting - The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaNot yet recruiting - Affiliated Zhongshan Hospital Of dalian UniversityDalian, ChinaNot yet recruiting - Affiliated Zhongshan Hospital Of dalian UniversityDalian, ChinaNot yet recruiting - Liaoning Cancer Research InstituteShenyang, ChinaNot yet recruiting - The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaNot yet recruiting And 13 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07367529) ## Related records ### Drugs (1) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) ### Lead sponsors (1) - [Chia Tai Tianqing Pharmaceutical Group Co., Ltd.](https://trialight.com/data/company/chia-tai-tianqing-pharmaceutical-group-co-ltd-9e0e36b9-4469-4cb3-8581-2c98292d5f0a.md) ### Conditions (1) - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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