Actively Recruiting
A Phase 2 Clinical Trial of TQB2102 for Injection in Locally Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Gene Abnormality to Evaluate the Efficacy and Safety
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-11-20
270
Participants Needed
25
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 (HER2) in patients with locally advanced or metastatic non-small cell lung cancer who have HER2 gene abnormalities. This Phase 2 study aims to assess the effectiveness and safety of TQB2102, which combines targeted antibody action with a potent drug payload that is normally too toxic for general use. Participants receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. Some participants will receive TQB2102 alone, while others will receive TQB2102 combined with Benmelstobart, another intravenous drug targeting programmed death ligand-1 (PD-L1). Both treatments are given over multiple cycles to evaluate their effects. During the study, participants will be closely monitored through various assessments including measuring tumor response over up to eight months, tracking survival, and recording any adverse events from the start of treatment until 28 days after the last dose. Researchers will also check for immune responses to the drug at several points during and after treatment. The total participation may last up to 18 months to gather comprehensive safety and effectiveness data.
CONDITIONS
Brief 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
- Aged between 18 and 75 years at the time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 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
- Have at least one measurable tumor lesion according to RECIST 1.1 criteria
- Female participants of childbearing potential must agree to use contraception during the study and for 6 months after, have a negative pregnancy test within 7 days before enrollment, and not be breastfeeding
- Male participants must agree to use contraception during the study and for 6 months after the study ends
You will not qualify if you...
- Diagnosed or treated for another cancer within 3 years before starting study medication
- Adverse effects from prior treatments have not recovered to mild or less (CTCAE 5.0 grade 1 or lower), except hair loss
- Major surgery, incision biopsy, or significant injury within 28 days before study treatment; minor surgeries like biopsy or bronchoscopy within 7 days
- Long-term unhealed wounds or broken bones
- History or current active lung diseases such as interstitial lung disease, radiation pneumonia, immune-related pneumonia, active pulmonary tuberculosis, pneumoconiosis, or other pneumonia grade 2 or higher
- Blood clot events like stroke, deep vein thrombosis, or pulmonary embolism within 6 months before treatment
- History of substance abuse or mental disorders affecting ability to abstain
- Any severe or uncontrolled diseases
- Received anticancer or investigational drug treatments within 28 days or 5 half-lives before first dose
- Treated with certain Chinese patent anti-tumor drugs within 1 week before first dose
- Local palliative radiotherapy within 2 weeks before first dose
- Repeated or recent drainage of serous effusion within 2 weeks before treatment
- Symptomatic or worsening brain metastases or cancerous meningitis; stable brain metastases may be eligible
- Severe bone injury from tumor metastasis such as fractures or spinal cord compression within 6 months or expected soon
- Pain from uncontrolled bone metastases
- Allergic to humanized monoclonal antibodies or any study drug components
- Received live attenuated vaccines within 4 weeks before treatment
- Any condition judged by investigators to pose safety risk or interfere 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 8 months
Participants receive intravenous infusions of TQB2102 for injection, alone or combined with Benmelstobart injection, every 3 weeks as treatment cycles for their non-small cell lung cancer with HER2 gene abnormality.
Visits every 3 weeks for infusion and assessments
Duration - Up to 10 months after treatment
Participants are monitored for safety and long-term outcomes including survival and adverse events after treatment ends.
Periodic visits for up to 10 months following the last dose
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
Q
Qiming Wang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here