Treatment for 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

This study is testing a new treatment called TQB2102 for people with advanced lung cancer that has a HER2 gene issue, to see if it helps when standard treatments haven't worked.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 25 sites (Fuzhou, Fujian and 24 other locations)
• Trial ID: NCT06496490 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial evaluates the efficacy and safety of TQB2102, an antibody-drug conjugate, in patients with locally advanced or metastatic non-small cell lung cancer that has a HER2 gene abnormality. The study involves administering TQB2102 alone or in combination with Benmelstobart injection to target tumor cells specifically while delivering a potent drug payload. Participants must have previously failed standard treatments and have measurable lesions to qualify for the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with inoperable, advanced non-small cell lung cancer and a HER2 gene abnormality who have not responded to prior treatments.

Not a fit: Patients with operable non-small cell lung cancer or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with HER2-positive non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise with similar antibody-drug conjugate approaches, indicating potential for success in this area.

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.

Where this trial is running

Fuzhou, Fujian and 24 other locations

• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Foshan First People's Hospital — Foshan, Guangdong, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (Not_yet_recruiting)
• The Second People's Hospital of Shenzhen — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Not_yet_recruiting)
• Harbin Medical University cancer hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Hunan Provincial Tumor Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• First Affiliated Hospital of Gannan Medical University — Ganzhou, Jiangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Sichuan Cancer Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• Leshan People's Hospital — Leshan, Sichuan, China (Not_yet_recruiting)
• Xinjiang Uygur Autonomous Region Cancer Hospital — Ürümqi, Xinjiang, China (Not_yet_recruiting)
• The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU — Wenzhou, Zhejiang, China (Not_yet_recruiting)
• Beijing Cancer Hospital — Beijing, China (Not_yet_recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute&Hpspital — Tianjin, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Li Zhang, Doctor

Conditions Non-Small Cell Lung Cancer