Clinical trial NCT06496490: A Clinical Trial of TQB2102 for Injection in 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Baseline up to 8 months
Secondary outcomes:
measure: Duration Of Remission (DOR)
timeFrame: Baseline up to 8 months
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to 8 months
measure: Overall Survival (OS)
timeFrame: Baseline up to 18 months
measure: 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.
measure: 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.
measure: 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).
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Zunyi
country: China
facility: The Second Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Harbin
country: China
facility: Harbin Medical University cancer hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial Tumor Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
state: Shandong
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Leshan
country: China
facility: Leshan People's Hospital
state: Sichuan
city: Ürümqi
country: China
facility: Xinjiang Uygur Autonomous Region Cancer Hospital
state: Xinjiang
city: Wenzhou
country: China
facility: The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute&Hpspital
Study officials:
References: