A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality

November 18, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
      • Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Tianjin, China, 300181
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute&Hpspital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Not yet recruiting
        • Foshan First People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Jiangmen, Guangdong, China, 529000
        • Not yet recruiting
        • Jiangmen Central Hospital
        • Contact:
        • Contact:
      • Shenzhen, Guangdong, China, 518035
        • Not yet recruiting
        • The Second People's Hospital of Shenzhen
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 53000
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
        • Contact:
          • Ruiling Ning, Master
          • Phone Number: 13517662412
          • Email: rlning@163.com
    • Guizhou
      • Zunyi, Guizhou, China, 563006
        • Not yet recruiting
        • The Second Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341099
        • Not yet recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130012
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Affiliated Cancer Hospital of Shandong First Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610040
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:
      • Leshan, Sichuan, China, 614099
        • Not yet recruiting
        • Leshan People's Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Not yet recruiting
        • Xinjiang Uygur Autonomous Region Cancer Hospital
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325015
        • Not yet recruiting
        • The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2102 for injection
Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
Drug: TQB2102 for injection
HER2 dual-antibody-drug Conjugate (ADC).
Experimental: TQB2102 for injection+Benmelstobart injection
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.
Drug: TQB2102 for injection combined with Benmelstobart injection
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline up to 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The severity of all adverse medical events after the first injection.
From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Duration Of Remission (DOR)
Time Frame: Baseline up to 8 months
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
Baseline up to 8 months
Progression-Free Survival (PFS)
Time Frame: Baseline up to 8 months
PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.
Baseline up to 8 months
Overall Survival (OS)
Time Frame: Baseline up to 18 months
OS defined as the time from the first injection to death from any cause.
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.
The occurrence of all adverse medical events after the first injection.
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).
Incidence of anti-drug antibody (ADA)
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2102-II-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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