What is TQB6411 studying for advanced lung cancer?

This trial is studying TQB6411 for Injection to evaluate its safety and effectiveness in treating advanced lung cancer. Researchers aim to find the best dose for further study and measure how well the cancer responds to this treatment. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Who may be eligible for this advanced lung cancer clinical trial?

Adults aged 18 to 75 years with confirmed lung cancer and good overall health may be eligible. Participants should have measurable tumors, an ECOG performance status of 0 or 1, and meet specific lab test requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced lung cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

ID07367529

Phase IbII Study of TQB6411 Injection to Treat Advanced Lung Cancer Evaluating Safety and Effectiveness in Patients Aged 18 to 75

Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-07-08

465

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of TQB6411 for Injection in adults with advanced lung cancer. This phase IbII clinical trial focuses on patients aged 18 to 75 years who have lung cancer confirmed by histology or cytology and meet specific health criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to determine the recommended phase II dosage and measure response rates over time. Participants will receive TQB6411 for Injection as the treatment, administered in cycles every 21 or 28 days. The study includes monitoring for response rates, disease control, duration of relief, progression-free survival, overall survival, adverse events, and the presence of anti-drug antibodies. Blood samples will be collected at specified cycles and timepoints before and after dosing to assess drug levels and immune responses. During the study, participants will be evaluated for tumor response using recognized criteria and undergo laboratory tests to monitor safety and drug effects. The study duration includes follow-ups up to three years for overall survival assessment. Participants will be regularly monitored for side effects and treatment efficacy to ensure comprehensive data collection throughout the trial period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Subjects voluntarily participate and sign informed consent
Age between 18 and 75 years
ECOG performance status score of 0 or 1
Expected survival greater than 12 weeks
At least one measurable lesion by RECIST v1.1
Laboratory values within specified limits including hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 90×10⁹/L, total bilirubin ≤ 1.5×ULN, ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastases), serum creatinine ≤ 1.3×ULN or creatinine clearance ≥ 50 mL/min, and coagulation tests ≤ 1.5×ULN
Lung cancer confirmed by histology or cytology
Willing to provide tumor tissue samples unless unsuitable or refusal of re-biopsy
Women of childbearing potential must use effective contraception and have a negative pregnancy test
Male subjects must use effective contraception during and 6 months after study completion

You will not qualify if you...

History or current other malignancies except certain treated or cured cancers
Diseases affecting intravenous injection or blood sampling
Unresolved adverse reactions from prior therapies above grade 1 CTCAE, except specified non-safety risks
Major surgery or significant injury within 4 weeks prior to first dose
Bleeding events grade ≥3 within 4 weeks prior to first dose
Thromboembolic events within 6 months prior to first dose
Active viral hepatitis not controlled or requiring treatment
Active syphilis, tuberculosis, or significant lung diseases including interstitial lung disease
History of psychotropic drug abuse or mental disorders
Prior or planned bone marrow or organ transplantation
History of hepatic encephalopathy
Significant cardiovascular diseases including specific heart dysfunctions and arrhythmias
Active or uncontrolled severe infection grade ≥2
Renal failure requiring dialysis
Immunodeficiency including HIV positivity
Uncontrolled autoimmune diseases needing immunosuppressants or steroids
Epilepsy requiring treatment
Poorly controlled diabetes (fasting glucose >10 mmol/L)
Recent chemotherapy, immunotherapy, or targeted therapy within defined washout periods
Use of antitumor traditional Chinese medicines within 1 week prior to first dose
Tumors invading major vessels or causing risk of fatal hemorrhage
Uncontrolled effusions requiring drainage
Certain metastases or spinal cord compression with recent symptoms or treatments
Known hypersensitivity to study drug or excipients
Prior treatment with specific EGFR/c-Met or topoisomerase I inhibitor therapies
Participation in other antitumor trials within 4 weeks prior to first dose
Any condition judged by investigator to risk safety or study completion

Research Team

Shengxiang Ren, Doctor

Zhijie Wang, Doctor

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Phase IbII Study of TQB6411 Injection to Treat Advanced Lung Cancer Evaluating Safety and Effectiveness in Patients Aged 18 to 75

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AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria