Actively Recruiting
A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-11-20
270
Participants Needed
25
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in locally advanced or metastatic non-small cell lung cancer with HER2 gene abnormality.
CONDITIONS
Official Title
A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years at time of consent
- Eastern cooperative oncology group (ECOG) score of 0 or 1
- Estimated survival time of at least 3 months
- Diagnosed with locally advanced, metastatic, or recurrent non-small cell lung cancer that is inoperable and not suitable for radical concurrent chemoradiotherapy
- Previous standard treatments have failed
- At least one measurable tumor lesion according to RECIST 1.1
- Female participants of childbearing age agree to use contraception during the study and for 6 months after, have a negative serum pregnancy test within 7 days before enrollment, and are non-lactating
- Male participants agree to use contraception during the study and for 6 months after study completion
You will not qualify if you...
- Diagnosed or treated for another malignancy within 3 years prior to treatment
- Unresolved adverse effects from prior treatments greater than CTCAE 5.0 level 1 (excluding hair loss)
- Major surgery, incision biopsy, or major trauma within 28 days prior to study treatment, or minor trauma (biopsy, bronchoscopy, chest drainage) within 7 days
- Long-term unhealed wounds or bone fractures
- History of interstitial lung disease, radiation pneumonia, immune-related pneumonia treated with steroids, or active non-infectious pneumonia with interstitial changes during screening
- Active pulmonary tuberculosis, pneumoconiosis, or other pneumonia grade 2 or higher, or severe lung function impairment confirmed by tests
- Arterial or deep vein thrombosis events within 6 months prior to treatment
- History of psychotropic substance abuse or mental disorders preventing abstinence
- Severe or uncontrolled diseases
- Any anticancer therapy or investigational drug treatment within 28 days or 5 half-lives prior to first dosing
- Use of Chinese patent anti-tumor drugs within 1 week before first administration
- Local palliative radiotherapy within 2 weeks before first dose
- Serous effusion requiring repeated drainage or recent therapeutic drainage within 2 weeks
- Symptomatic or progressive central nervous system metastases or cancerous meningitis with diffuse spread; clinically stable brain metastases may be allowed
- Severe bone injury from tumor metastasis including pathological fractures or spinal cord compression within 6 months or likely to occur soon
- Pain from uncontrolled bone metastases
- Allergy to humanized monoclonal antibody products or any investigational drug ingredients
- Receipt of live attenuated vaccine within 4 weeks prior to treatment
- Any concomitant disease or condition deemed by the investigator to seriously endanger safety or interfere with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
2
Foshan First People's Hospital
Foshan, Guangdong, China, 528000
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
4
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
5
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518035
Not Yet Recruiting
6
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 53000
Not Yet Recruiting
7
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563006
Not Yet Recruiting
8
Harbin Medical University cancer hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
9
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
10
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
11
Hunan Provincial Tumor Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
12
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
13
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China, 341099
Not Yet Recruiting
14
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
15
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Not Yet Recruiting
16
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
17
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
18
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
19
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610040
Not Yet Recruiting
20
Leshan People's Hospital
Leshan, Sichuan, China, 614099
Not Yet Recruiting
21
Xinjiang Uygur Autonomous Region Cancer Hospital
Ürümqi, Xinjiang, China, 830001
Not Yet Recruiting
22
The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
Wenzhou, Zhejiang, China, 325015
Not Yet Recruiting
23
Beijing Cancer Hospital
Beijing, China, 100142
Not Yet Recruiting
24
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Not Yet Recruiting
25
Tianjin Medical University Cancer Institute&Hpspital
Tianjin, China, 300181
Not Yet Recruiting
Research Team
L
Li Zhang, Doctor
CONTACT
Q
Qiming Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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