Actively Recruiting
A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB6411 for Injection in Patients With Advanced Lung Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-05-05
465
Participants Needed
37
Research Sites
N/A
Total Duration
On this page
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 Ib/II clinical trial aims to determine the best dosage for phase II treatment and assess how well the drug works in controlling the disease. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and focuses on patients with measurable lung cancer lesions and a good overall health status. Participants receive TQB6411 for Injection every 21 days as a treatment cycle. The study monitors several important outcomes, including the recommended phase II dosage, objective response rate, disease control rate, duration of relief, progression-free survival, overall survival, and adverse events. Blood samples are collected at specific times to measure drug concentration and immune response. The trial includes ongoing assessment of safety and efficacy over periods ranging from weeks to years. During the study, participants will have regular visits for physical exams, laboratory tests, and tumor assessments following RECIST v1.1 criteria. Researchers will also monitor for any side effects and immune reactions to the drug. Participants must agree to provide tumor tissue samples for testing unless unavailable or unsuitable. The total involvement can last up to several years, with continuous evaluations to track treatment effects and safety.
CONDITIONS
Brief Title
A Clinical Trial on the Efficacy and Safety of TQB6411 for Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 to 75 years at consent
- ECOG performance status of 0 or 1
- Expected survival longer than 12 weeks
- At least one measurable tumor lesion per RECIST v1.1
- Laboratory values within specified limits (e.g., hemoglobin ≥90 g/L, neutrophils ≥1.5×10⁹/L, platelets ≥90×10⁹/L)
- Lung cancer confirmed by histology or cytology
- Willing to provide tumor tissue samples for testing if available
- Women of childbearing potential must use effective contraception during and for 6 months after study
- Male participants must use effective contraception during and for 6 months after study
You will not qualify if you...
- History or current other cancers except certain cured or non-invasive types
- Conditions affecting intravenous injection or blood sampling
- Unresolved adverse reactions from prior therapies above grade 1 (with exceptions)
- Major surgery or significant injury within 4 weeks prior to first dose
- Recent bleeding events grade 3 or higher within 4 weeks
- Recent arterial or venous thromboembolic events within 6 months
- Active or poorly controlled viral hepatitis or active syphilis
- Active tuberculosis or serious lung diseases including interstitial lung disease
- History of psychotropic drug abuse or mental disorders
- Prior or planned bone marrow or organ transplantation
- Significant cardiovascular diseases or arrhythmias
- Active or uncontrolled severe infection
- Renal failure requiring dialysis
- Immunodeficiency including HIV
- Uncontrolled autoimmune diseases needing immunosuppressants
- Epilepsy requiring treatment
- Poorly controlled diabetes
- Recent chemotherapy, immunotherapy, or targeted therapy within 3 weeks
- Tumors invading major vessels or causing uncontrolled symptoms
- Known allergy to study drug or excipients
- Prior treatment with specific EGFR/c-Met targeted therapies with severe toxicity
- Participation in other antitumor trials within 4 weeks
- Any other conditions judged unsafe or interfering with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive TQB6411 for Injection every 21 days as a treatment cycle.
Visits every 21 days for treatment administration and assessments
Duration - Up to 3 years
Participants are monitored for safety and efficacy outcomes after treatment ends.
Periodic visits during follow-up period
Trial Site Locations
Total: 37 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Beijing Chest Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 101100
Not Yet Recruiting
3
Chongqing University Affiliated Three Gorges Hospital
Chongqing, Chongqing Municipality, China, 404000
Not Yet Recruiting
4
The first affiliated hospital of Guangzhou medical university
Guangzhou, Guangdong, China, 510120
Not Yet Recruiting
5
The first affiliated hospital of Guangzhou medical university
Guanzhou, Guangdong, China, 510120
Not Yet Recruiting
6
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 528445
Not Yet Recruiting
7
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 53000
Not Yet Recruiting
8
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 53000
Not Yet Recruiting
9
Cangzhou Central hospital
Cangzhou, Hebei, China, 61000
Not Yet Recruiting
10
Cangzhou Central hospital
Cangzhou, Hebei, China, 61000
Not Yet Recruiting
11
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
12
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
13
Anyang People's Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
14
Luoyang Central Hospital (Zhengzhou University Affiliated Luoyang Central Hospital)
Luoyang, Henan, China, 471000
Not Yet Recruiting
15
Nanyang Second General Hospital
Nanyang, Henan, China, 473012
Not Yet Recruiting
16
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Not Yet Recruiting
17
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
18
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjin, Jiangsu, China, 210019
Not Yet Recruiting
19
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
20
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225000
Not Yet Recruiting
21
Affiliated Zhongshan Hospital Of dalian University
Dalian, Liaoning, China, 116001
Not Yet Recruiting
22
Affiliated Zhongshan Hospital Of dalian University
Dalian, Liaoning, China, 116001
Not Yet Recruiting
23
Liaoning Cancer Research Institute
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
24
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
25
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
26
Shandong First Medical University Affiliated Tumor Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
27
Linyi cancer Hospital
Linyi, Shandong, China, 276034
Not Yet Recruiting
28
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Not Yet Recruiting
29
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Not Yet Recruiting
30
First Hospital of Shangxi Medical University
Taiyuan, Shangxi, China, 030001
Not Yet Recruiting
31
Shanxi Cancer hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
32
Shanxi Cancer hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
33
The Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China, 710000
Not Yet Recruiting
34
Sichuan cancer hosipital
Chengdu, Sichuan, China, 610040
Not Yet Recruiting
35
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
36
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
37
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 317000
Not Yet Recruiting
Research Team
S
Shengxiang Ren, Doctor
Z
Zhijie Wang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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