Non-Small Cell Lung CancerPhase 2NCT06496490
A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality
A Phase 2 study testing TQB2102 for injection and TQB2102 for injection combined with Benmelstobart injection in people with Non-Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 25 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- TQB2102 for injection and TQB2102 for injection combined with Benmelstobart injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 25 sitesChina
- Study dates
- 6 Aug 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study and sign informed consent;
- Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
- Patients with locally advanced, metastatic, or recurrent non-small cell lung cancer that is cytologically or histologically proven to be inoperable and cannot be treated with radical concurrent chemoradiotherapy;
- Previous standard treatments failed；
- At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
- Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.
Who cannot join
- Has diagnosed and/or treated additional malignancy within 3 years prior to take medication;
- Adverse effects due to any prior treatment have not been restored to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
- Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment,and minor traumatic surgery (biopsy, bronchoscopy, and chest drainage) within 7 days;
- Long-term unhealed wounds or fractures;
- History of interstitial lung disease, radiation pneumonia, and immune-related pneumonia treated with steroids in the past, or active non-infectious pneumonia with interstitial changes such as interstitial lung disease, radiation pneumonia, and immune-related pneumonia in the screening period, active pulmonary tuberculosis, pneumoconiosis, or other types of pneumonia ≥ grade 2, or severe impairment of lung function confirmed by pulmonary function examination;
- Arterial/deep vein thrombosis events occurred within 6 months prior to treatment, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
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- Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
- Patients with any severe and/or uncontrolled disease;
- Any anticancer therapy or any other investigational drug treatment within 28 days or 5 half-lives prior to the first dosing of this study;
- Within 1 week prior to the first administration of this study, the Chinese patent drugs with anti-tumor indications clearly stated in the National MedicalProducts Administration approved drug instructions were treated;
- Local focal palliative radiotherapy was received within 2 weeks before the first dose;
- Patients with serous effusion requiring repeated drainage to relieve clinical symptoms or who have received serous effusion drainage for therapeutic purposes within 2 weeks prior to treatment;
- There is symptomatic or progressive exacerbation of central nervous system metastatic or cancerous meningitis with diffuse spread. Subjects with a history of brain metastases may be considered for inclusion if they are clinically stable;
- Severe bone injury caused by tumor bone metastasis, including pathological fractures and spinal cord compression that occurred within 6 months or are likely to occur in the near future;
- Pain associated with uncontrolled bone metastases;
- Allergic to humanized monoclonal antibody products;
- Allergic to any investigational drug or to any ingredient or excipient in the drug;
- Persons who have received live attenuated vaccine within 4 weeks prior to treatment;
- Subjects who, in the investigator's judgment, have concomitant diseases that seriously endanger the safety of subjects or interfere with the completion of the study, or who are deemed unsuitable for enrollment for other reasons.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
China25 sites, 25 recruiting
- Not yet recruiting
Beijing Cancer Hospital
Beijing, 100142
Jian Fang, Doctor, 010-88196479, fangjian5555@yeah.net
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Shuang Zhang, Doctor, 13074321168, zhangshuangphy@126.com
- Not yet recruiting
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410031
Xingxiang Pu, Doctor, 15874180022, puxingxiang@hnca.org.cn
Lemeng Zhang, Doctor, 18684689890, zhanglemeng@hnca.org.cn
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000
Haitao Lan, Master, 18981838376, lanht@sina.com
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610040
Jin Zhou, Doctor, 18908190355, zhoujt521@163.com
- Not yet recruiting
Foshan First People's Hospital
Foshan, Guangdong, 528000
Jun Jiang, Master, 18038865018, 2290836829@qq.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Haipeng Xu, Doctor, 13675007687, penghaixu@163.com
- Not yet recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341099
Jie Li, Doctor, 15979779931, juel1024@126.com
Ruilian Xie, Master, 15083737536, xieruilian163@163.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, Doctor, 020-87343458, Zhangli6@mail.sysu.edu.cn
- Not yet recruiting
Harbin Medical University cancer hospital
Harbin, Heilongjiang, 150081
Baogang Liu, Doctor, 13804552752, liubaogang1962@sina.com
- Not yet recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Daren Lin, Bachelor, 13802607246, ldrdy@sina.com
Min Ye, Bachelor, 13902889916, yeminzhangcuiyuan@126.com
- Not yet recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Linlin Wang, Doctor, 13793187739, wanglinlinatjn@163.com
- Not yet recruiting
Leshan People's Hospital
Leshan, Sichuan, 614099
Hailong Wei, Master, 13890689715, 13890689715@163.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Longhua Sun, Doctor, 18279110112, 48570887@qq.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Renhua Guo, Doctor, 13585145540, guorenhua@csco.ac.cn
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 53000
Qitao Yu, Bachelor, 19163771333, yqt178@163.com
Ruiling Ning, Master, 13517662412, rlning@163.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Junhua Zhang, Doctor, 18017317850, zhangjunhua20005@163.com
- Not yet recruiting
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035
Hao Wu, Doctor, 13828810320, haowudr@hotmail.com
- Not yet recruiting
Tianjin Medical University Cancer Institute&Hpspital
Tianjin, 300181
Dingzhi Huang, Doctor, 18622221232, zlyyfnkdoc@163.com
- Not yet recruiting
Xinjiang Uygur Autonomous Region Cancer Hospital
Ürümqi, Xinjiang, 830001
ChunLing Liu, Master, 13899931987, liudeyouxiang66@163.com
- Not yet recruiting
The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
Wenzhou, Zhejiang, 325015
Yuping Li, Master, 13587600968, wzliyp@163.com
- Not yet recruiting
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Rui Meng, Doctor, 13995612493, mengruivip@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Yu Yang, Doctor, 13572101611, Oncology_yao@163.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Qiming Wang, Doctor, 13783590691, qimingwang1006@126.com
- Not yet recruiting
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563006
Jianguo Zhou, Doctor, 18785237902, jianguo905@163.com
About this study
Official title: 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
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
- Non-Small Cell Lung Cancer
- Being tested
- TQB2102 for injection, TQB2102 for injection combined with Benmelstobart injection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102 for injectionDrug
HER2 dual-antibody-drug Conjugate (ADC).
TQB2102 for injection combined with Benmelstobart injectionDrug
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC); Benmelstobart injection is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 for injection | Experimental | Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle. Receives: Drug: TQB2102 for injection |
| TQB2102 for injection+Benmelstobart injection | Experimental | TQB2102 for injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle; Benmelstobart injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle. Receives: Drug: TQB2102 for injection combined with Benmelstobart injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).
Measured: Baseline up to 8 months
Secondary outcomes (6)
Duration Of Remission (DOR)
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
Measured: Baseline up to 8 months
Progression-Free Survival (PFS)
PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.
Measured: Baseline up to 8 months
Overall Survival (OS)
OS defined as the time from the first injection to death from any cause.
Measured: Baseline up to 18 months
Frequency of adverse event (AE)
The occurrence of all adverse medical events after the first injection.
Measured: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Severity of adverse event (AE)
The severity of all adverse medical events after the first injection.
Measured: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Anti-drug antibody (ADA)
Incidence of anti-drug antibody (ADA)
Measured: Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days), 90 days after the end of the last infusion (each cycle is 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start6 Aug 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496490
- Sponsor's protocol ID
- TQB2102-II-03
- Status last verified
- Sep 2025
- First submitted
- 4 Jul 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06496490
- Acronym / sponsor ID
- TQB2102-II-03
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2102 for injection | Experimental | Drug: TQB2102 for injectionIntravenous infusion, administered every 3 weeks, 21 days as a treatment cycle. |
| TQB2102 for injection+Benmelstobart injection | Experimental | Drug: TQB2102 for injection combined with Benmelstobart injectionTQB2102 for injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle; Benmelstobart injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects voluntarily participate in this study and sign informed consent;
- Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
- Patients with locally advanced, metastatic, or recurrent non-small cell lung cancer that is cytologically or histologically proven to be inoperable and cannot be treated with radical concurrent chemoradiotherapy;
- Previous standard treatments failed；
- At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
Key exclusion criteria (19 listed)
- Has diagnosed and/or treated additional malignancy within 3 years prior to take medication;
- Adverse effects due to any prior treatment have not been restored to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
- Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment,and minor traumatic surgery (biopsy, bronchoscopy, and chest drainage) within 7 days;
- Long-term unhealed wounds or fractures;
- History of interstitial lung disease, radiation pneumonia, and immune-related pneumonia treated with steroids in the past, or active non-infectious pneumonia with interstitial changes such as interstitial lung disease, radiation pneumonia, and immune-related pneumonia in the screening period, active pulmonary tuberculosis, pneumoconiosis, or other types of pneumonia ≥ grade 2, or severe impairment of lung function confirmed by pulmonary function examination;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2102 for injectionHER2 dual-antibody-drug Conjugate (ADC). | Drug | TQB2102 for injection |
| TQB2102 for injection combined with Benmelstobart injectionTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC); Benmelstobart injection is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1). | Drug | TQB2102 for injection+Benmelstobart injection |
Primary outcome
Overall Response Rate (ORR)
Time frame: Baseline up to 8 months
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).
6 secondary outcomes
Duration Of Remission (DOR)
Time frame: Baseline up to 8 months
Progression-Free Survival (PFS)
Time frame: Baseline up to 8 months
Overall Survival (OS)
Time frame: Baseline up to 18 months
Frequency of adverse event (AE)
Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Severity of adverse event (AE)
Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Anti-drug antibody (ADA)
Time frame: Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days), 90 days after the end of the last infusion (each cycle is 21 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB2102 for injection and TQB2102 for injection combined with Benmelstobart injection in people with Non-Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 25 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, Doctor (020-87343458, Zhangli6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Baseline up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.