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

NCT06496490
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
270
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Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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Start date
2024-08-06
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Number of sites
25
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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.
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Short title
A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-12-01
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First posted
2024-07-11
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Registry last updated
2025-11-20
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Primary completion date
2026-06-01
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Start date
2024-08-06
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Participants
270
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Participant count basis
Estimated
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Planned participants
270
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Protocol amendments
1
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Number of sites
25
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Registry sponsor category
Industry
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Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06496490
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ClinicalTrials.gov ID
NCT06496490
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Registry record
Open registry record
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Allocation
Not applicable
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Overall Response Rate (ORR)

    Timeframe: Baseline up to 8 months

    ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).

  1. Duration Of Remission (DOR)

    Timeframe: Baseline up to 8 months

    DOR defined as the time when the participants first achieved complete or partial remission to disease progression.

  2. Progression-Free Survival (PFS)

    Timeframe: 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.

  3. Overall Survival (OS)

    Timeframe: Baseline up to 18 months

    OS defined as the time from the first injection to death from any cause.

  4. Frequency of adverse event (AE)

    Timeframe: 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.

  5. Severity of adverse event (AE)

    Timeframe: 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.

  6. Anti-drug antibody (ADA)

    Timeframe: 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)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • Fujian Cancer HospitalFuzhou, ChinaRecruiting
  • Foshan First People's HospitalFoshan, ChinaNot yet recruiting
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaNot yet recruiting
  • Jiangmen Central HospitalJiangmen, ChinaNot yet recruiting
  • The Second People's Hospital of ShenzhenShenzhen, ChinaNot yet recruiting
  • Guangxi Medical University Cancer HospitalNanning, ChinaNot yet recruiting
  • The Second Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaNot yet recruiting
  • Harbin Medical University cancer hospitalHarbin, ChinaNot yet recruiting
  • Henan Cancer HospitalZhengzhou, ChinaNot yet recruiting
  • Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNot yet recruiting
  • Hunan Provincial Tumor HospitalChangsha, ChinaNot yet recruiting
  • Jiangsu Provincial People's HospitalNanjing, ChinaNot yet recruiting
  • First Affiliated Hospital of Gannan Medical UniversityGanzhou, ChinaNot yet recruiting
  • The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaNot yet recruiting
  • Jilin Cancer HospitalChangchun, ChinaNot yet recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaNot yet recruiting
  • Affiliated Cancer Hospital of Shandong First Medical UniversityJinan, ChinaNot yet recruiting
  • Sichuan Provincial People's HospitalChengdu, ChinaNot yet recruiting
  • Sichuan Cancer HospitalChengdu, ChinaNot yet recruiting
  • Leshan People's HospitalLeshan, ChinaNot yet recruiting
  • Xinjiang Uygur Autonomous Region Cancer HospitalÜrümqi, ChinaNot yet recruiting
  • The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMUWenzhou, ChinaNot yet recruiting
  • Beijing Cancer HospitalBeijing, ChinaNot yet recruiting
  • Fudan University Shanghai Cancer CenterShanghai, ChinaNot yet recruiting
  • Tianjin Medical University Cancer Institute&HpspitalTianjin, ChinaNot yet recruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)