New drug TQB6411 aims to fight advanced lung cancer

NCT ID NCT07367529

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 4 times

Summary

This clinical trial is testing a new drug called TQB6411 in people with advanced lung cancer. The study has two phases: first to find the best dose, then to see how well it works. About 465 participants will receive the drug every 21 days. Researchers will measure tumor shrinkage, how long the effect lasts, and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TQB6411
What this could lead to: If successful, this could lead to a new treatment option for advanced lung cancer, potentially shrinking tumors or slowing disease progression.
What could go wrong: This is an early-phase trial (phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause unexpected side effects. Results may not apply to all lung cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 465 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; * 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 and amplification testing, unless the participant 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 participants 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 participants with HepatitisBvirus 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 participants (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 (participants 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 participant safety or study completion.

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Conditions

The condition(s) this trial relates to.

lung cancer lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

38 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Affiliated Zhongshan Hospital Of dalian University
NOT_YET_RECRUITING

Dalian, Liaoning, 116001, China
Affiliated Zhongshan Hospital Of dalian University
NOT_YET_RECRUITING

Dalian, Liaoning, 116001, China
Anyang People's Hospital
NOT_YET_RECRUITING

Anyang, Henan, 455000, China
Beijing Chest Hospital，Capital Medical University
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 101100, China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING

Beijing, Beijing Municipality, 100021, China
Cangzhou Central hospital
NOT_YET_RECRUITING

Cangzhou, Hebei, 61000, China
Cangzhou Central hospital
NOT_YET_RECRUITING

Cangzhou, Hebei, 61000, China
Chongqing University Affiliated Three Gorges Hospital
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 404000, China
First Hospital of Shangxi Medical University
NOT_YET_RECRUITING

Taiyuan, Shangxi, 030001, China
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING

Nanning, Guangxi, 53000, China
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING

Nanning, Guangxi, 53000, China
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150000, China
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING

Harbin, Heilongjiang, 150000, China
Jiangsu Provincial Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING

Nanjin, Jiangsu, 210019, China
Liaoning Cancer Research Institute
NOT_YET_RECRUITING

Shenyang, Liaoning, 110000, China
Linyi cancer Hospital
NOT_YET_RECRUITING

Linyi, Shandong, 276034, China
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
NOT_YET_RECRUITING

Luoyang, Henan, 471000, China
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210000, China
Nanyang Second General Hospital
NOT_YET_RECRUITING

Nanyang, Henan, 473012, China
Northern Jiangsu People's Hospital
NOT_YET_RECRUITING

Yangzhou, Jiangsu, 225000, China
Shandong First Medical University Affiliated Tumor Hospital
NOT_YET_RECRUITING

Jinan, Shandong, 250117, China
Shandong First Medical University Affiliated Tumor Hospital
NOT_YET_RECRUITING

Jinan, Shandong, 250117, China
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200433, China
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200433, China
Shanxi Cancer hospital
NOT_YET_RECRUITING

Taiyuan, Shanxi, 030000, China
Shanxi Cancer hospital
NOT_YET_RECRUITING

Taiyuan, Shanxi, 030000, China
Sichuan cancer hosipital
NOT_YET_RECRUITING

Chengdu, Sichuan, 610040, China

Contact Email: •••••@•••••
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310009, China
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING

Taizhou, Zhejiang, 317000, China
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING

Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710000, China
The Second Affiliated Hospital of Air Force Medical University
NOT_YET_RECRUITING

Xi’an, Shanxi, 710000, China
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410000, China
The first affiliated hospital of Guangzhou medical university
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510120, China
The first affiliated hospital of Guangzhou medical university
NOT_YET_RECRUITING

Guanzhou, Guangdong, 510120, China
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300000, China
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING

Wuhan, Hubei, 430071, China
Zhongshan City People's Hospital
NOT_YET_RECRUITING

Zhongshan, Guangdong, 528445, China

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