A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality
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
1 other identifier
interventional
270
1 country
25
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Aug 2024
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2024
CompletedFirst Posted
Study publicly available on registry
July 11, 2024
CompletedStudy Start
First participant enrolled
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 20, 2025
September 1, 2025
1.8 years
July 4, 2024
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).
Baseline up to 8 months
Secondary Outcomes (6)
Duration Of Remission (DOR)
Baseline up to 8 months
Progression-Free Survival (PFS)
Baseline up to 8 months
Overall Survival (OS)
Baseline up to 18 months
Frequency of adverse event (AE)
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)
From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
- +1 more secondary outcomes
Study Arms (2)
TQB2102 for injection
EXPERIMENTALIntravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
TQB2102 for injection+Benmelstobart injection
EXPERIMENTALTQB2102 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Foshan First People's Hospital
Foshan, Guangdong, 528000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 53000, China
The Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563006, China
Harbin Medical University cancer hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410031, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341099, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610040, China
Leshan People's Hospital
Leshan, Sichuan, 614099, China
Xinjiang Uygur Autonomous Region Cancer Hospital
Ürümqi, Xinjiang, 830001, China
The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
Wenzhou, Zhejiang, 325015, China
Beijing Cancer Hospital
Beijing, 100142, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Tianjin Medical University Cancer Institute&Hpspital
Tianjin, 300181, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2024
First Posted
July 11, 2024
Study Start
August 6, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 20, 2025
Record last verified: 2025-09