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A Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04306926
Recruitment Status : Not yet recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Condition or disease Intervention/treatment Phase
Advanced Oligometastatic Non-small Cell Lung Cancer Drug: TQB2450 Radiation: SBRT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open-label, Single-arm, Phase II Study of TQB2450 Injection Combined With Stereotactic Body Radiation Therapy (SBRT) in Subjects With Advanced Oligometastatic Non-Small Cell Lung Cancer
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TQB2450+SBRT
SBRT three days before TQB2450.
Drug: TQB2450
TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.

Radiation: SBRT
Give according to the location of the lesion and clinical condition.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Baseline up to 96 weeks ]
    PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Baseline up to 96 weeks ]
    Percentage of subjects achieving complete response (CR) and partial response (PR).

  2. Overall survival (OS) [ Time Frame: Baseline up to 96 weeks ]
    OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

  3. Disease control rate(DCR) [ Time Frame: Baseline up to 96 weeks ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months.

    2. Histologically or pathologically confirmed advanced non-small cell lung cancer.

    3. Primary lesion controlled oligometastatic patients, the number of metastatic lesions ≤ 5, and has at least one measurable lesion.

    4. Has received standard first-line chemotherapy, intolerable or inappropriate to the chemotherapy.

    5. Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.

    7.Understood and Signed an informed consent form.

Exclusion Criteria:

  • 1. Has used against PD-1, PD-L1 and other related immunotherapeutic drugs. 2.Has mutations in (epidermal growth factor receptor)EGFR, (anaplastic lymphoma kinase)ALK, (c-ros oncogene 1 receptor kinase)ROS1 or T790M and not resistant to targeted drug.

    3. Has severe hypersensitivity reaction to other monoclonal antibodies. 4. Has diagnosed and/or treated additional malignancy within 5 years prior to the first administration.Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.

    5. Has any active autoimmune disease or a history of autoimmune disease. 6. Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration.

    7. (Magnetic Resonance Imaging)MRI examination found meningeal metastases and cannot be controlled by stereotactic radiotherapy.

    8. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

    9. Has any severe and/or uncontrolled disease. 10. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.

    11. According to the judgement of the researchers, there are other factors that may lead to the termination of the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306926


Contacts
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Contact: Hongqing Zhuang, Doctor 010-82264931 hongqingzhuang@163.com

Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Contact: Huiming Yu, Doctor         
Principal Investigator: Huiming Yu, Doctor         
Peking University Third Hospital
Beijing, Beijing, China, 100191
Contact: Hongqing Zhuang, Doctor       hongqingzhuang@163.com   
Principal Investigator: Hongqing Zhuang, Doctor         
China, Shanghai
Huashan Hospital Fudan University
Shanghai, Shanghai, China, 200040
Contact: Enmin Wang, Doctor         
Principal Investigator: Enmin Wang, Doctor         
China, Tianjin
Tianjin Medical University Cancer institute and Hospital
Tianjin, Tianjin, China, 300060
Contact: Zhiyong Yuan, Doctor         
Principal Investigator: Zhiyong Yuan, Doctor         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04306926    
Other Study ID Numbers: TQB2450-II-05
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms