Treatment for Non-small Cell Lung Cancer with HER2 Gene Abnormality
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
Run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · NCT06496490 · Data updated 2026-11-12
This study is testing a new treatment called TQB2102 for people with advanced lung cancer that has a HER2 gene issue, to see if it helps when standard treatments haven't worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 25 sites (Fuzhou, Fujian and 24 other locations) |
| Status | Recruiting |
| Started | August 6, 2024 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT06496490 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with inoperable, advanced non-small cell lung cancer and a HER2 gene abnormality who have not responded to prior treatments.
✕Probably not a fit
Patients with operable non-small cell lung cancer or those who have not yet undergone standard treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 clinical trial evaluates the efficacy and safety of TQB2102, an antibody-drug conjugate, in patients with locally advanced or metastatic non-small cell lung cancer that has a HER2 gene abnormality. The study involves administering TQB2102 alone or in combination with Benmelstobart injection to target tumor cells specifically while delivering a potent drug payload. Participants must have previously failed standard treatments and have measurable lesions to qualify for the trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with HER2-positive non-small cell lung cancer.
How similar studies have gone: Other studies have shown promise with similar antibody-drug conjugate approaches, indicating potential for success in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.
Where it's running
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Fujian Cancer Hospital
Fuzhou, Fujian, China Recruiting -
Foshan First People's Hospital
Foshan, Guangdong, China Not yet recruiting -
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China Not yet recruiting -
Jiangmen Central Hospital
Jiangmen, Guangdong, China Not yet recruiting -
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China Not yet recruiting -
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China Not yet recruiting
Show 19 more locations
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The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China Not yet recruiting -
Harbin Medical University cancer hospital
Harbin, Heilongjiang, China Not yet recruiting -
Henan Cancer Hospital
Zhengzhou, Henan, China Not yet recruiting -
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Not yet recruiting -
Hunan Provincial Tumor Hospital
Changsha, Hunan, China Not yet recruiting -
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China Not yet recruiting -
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China Not yet recruiting -
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China Not yet recruiting -
Jilin Cancer Hospital
Changchun, Jilin, China Not yet recruiting -
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China Not yet recruiting -
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China Not yet recruiting -
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China Not yet recruiting -
Sichuan Cancer Hospital
Chengdu, Sichuan, China Not yet recruiting -
Leshan People's Hospital
Leshan, Sichuan, China Not yet recruiting -
Xinjiang Uygur Autonomous Region Cancer Hospital
Ürümqi, Xinjiang, China Not yet recruiting -
The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
Wenzhou, Zhejiang, China Not yet recruiting -
Beijing Cancer Hospital
Beijing, China Not yet recruiting -
Fudan University Shanghai Cancer Center
Shanghai, China Not yet recruiting -
Tianjin Medical University Cancer Institute&Hpspital
Tianjin, China Not yet recruiting
Study contacts
- Study coordinator: Li Zhang, Doctor
- Email: Zhangli6@mail.sysu.edu.cn
- Phone: 020-87343458
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.