New smart drug targets HER2 lung cancer in Mid-Stage trial
NCT ID NCT06496490
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing TQB2102, a drug that combines an antibody with chemotherapy to specifically attack lung cancer cells that have HER2 gene abnormalities. The study will enroll 270 adults with advanced non-small cell lung cancer that cannot be surgically removed. Researchers will measure how many patients' tumors shrink or disappear, and how long that effect lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQB2102 (a targeted antibody-drug conjugate that delivers chemotherapy directly to cancer cells with HER2 abnormalities)
- What this could lead to
- If successful, this could provide a new treatment option for people with advanced lung cancer that has specific HER2 gene changes, potentially shrinking tumors and delaying disease progression.
- What could go wrong
- This is a mid-stage trial with only 270 participants, so results may not apply to everyone. The drug can cause side effects like any chemotherapy, and it may not work for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 270 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
25 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITINGJinan, Shandong, 250117, China
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Beijing Cancer Hospital
NOT_YET_RECRUITINGBeijing, 100142, China
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First Affiliated Hospital of Gannan Medical University
NOT_YET_RECRUITINGGanzhou, Jiangxi, 341099, China
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Foshan First People's Hospital
NOT_YET_RECRUITINGFoshan, Guangdong, 528000, China
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Fudan University Shanghai Cancer Center
NOT_YET_RECRUITINGShanghai, 200032, China
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Fujian Cancer Hospital
RECRUITINGFuzhou, Fujian, 350014, China
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Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITINGNanning, Guangxi, 53000, China
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Harbin Medical University cancer hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150081, China
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Henan Cancer Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
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Hunan Provincial Tumor Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410031, China
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Jiangmen Central Hospital
NOT_YET_RECRUITINGJiangmen, Guangdong, 529000, China
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Jiangsu Provincial People's Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Jilin Cancer Hospital
NOT_YET_RECRUITINGChangchun, Jilin, 130012, China
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Leshan People's Hospital
NOT_YET_RECRUITINGLeshan, Sichuan, 614099, China
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Sichuan Cancer Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610040, China
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Sichuan Provincial People's Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610000, China
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510060, China
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The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
NOT_YET_RECRUITINGWenzhou, Zhejiang, 325015, China
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The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, 330006, China
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The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi'an, Shaanxi, 710000, China
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The Second Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITINGZunyi, Guizhou, 563006, China
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The Second People's Hospital of Shenzhen
NOT_YET_RECRUITINGShenzhen, Guangdong, 518035, China
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Tianjin Medical University Cancer Institute&Hpspital
NOT_YET_RECRUITINGTianjin, 300181, China
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Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, 430000, China
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Xinjiang Uygur Autonomous Region Cancer Hospital
NOT_YET_RECRUITINGÜrümqi, Xinjiang, 830001, China
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