A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer
NCT ID: NCT05913089
Last Updated: 2023-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
58 participants
INTERVENTIONAL
2023-06-14
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TQB2450 injection + Chemotherapy
TQB2450 injection combined with chemotherapy, 21 days as a treatment cycle.
TQB2450 injection + Chemotherapy
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1).
Chemotherapy is a systematic treatment that kill fast growing cells.
TQB2450 injection + Anlotinib Hydrochloride Capsule
TQB2450 injection combined with anlotinib hydrochloride capsule, 21 days as a treatment cycle.
TQB2450 injection + Anlotinib Hydrochloride Capsule
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1).
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Interventions
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TQB2450 injection + Chemotherapy
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1).
Chemotherapy is a systematic treatment that kill fast growing cells.
TQB2450 injection + Anlotinib Hydrochloride Capsule
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1).
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old (calculated on the date of signing the informed consent); Both men and women; Eastern Cooperative Oncology Group (ECOG) score 0\~1; Predicted survival ≥3 months;
* Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria within 28 days prior to initiation of treatment;
* Has not received systemic antitumor therapy, including radiotherapy, chemotherapy and immunotherapy;
* Agree to provide fresh or 6 month tumor tissue for programmed death ligand -1 (PD-L1) testing.
* Major organs are functioning well.
* Women of reproductive age should agree that they must use effective birth control during the study period and for 6 months after the study, and that a negative serum or urine pregnancy test occurred within 7 days prior to study enrollment; Men should agree that effective contraception must be used during the study period and for 6 months after the study period ends.
* The subjects voluntarily joined the study and signed the informed consent with good compliance.
Exclusion Criteria
* Subjects are known to have genetic abnormalities with approved targeted drug therapy.
* Cirrhosis, active hepatitis;
* Cardio-cerebrovascular abnormalities;
* Subjects with severe active infection within 4 weeks prior to initiation of study treatment; Or unexplained fever \>38.0 ℃ occurred during screening and before first administration;
* Patients with active tuberculosis within 1 year prior to enrollment;
* Immunodeficiency disease;
* History of active autoimmune disease or autoimmune disease;
* Preparing for or having previously received an organ transplant, or having received a hematopoietic stem cell transplant within 60 days prior to initial medication, or having a significant host transplant response;
* Patients who required immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and continued use within two weeks prior to randomization
* Severe infection of grade 4 or higher occurred within 1 year prior to initiation of study therapy;
* Severe lung disease;
* History of pituitary or adrenal dysfunction;
* History of severe mental disorder;
* History of drug abuse, alcoholism or drug use;
* Participated in clinical trials of other drugs within 30 days;
* History of live attenuated vaccine vaccination within 28 days prior to randomization or planned live attenuated vaccine vaccination during the study period;
* Received Chinese patent drugs with anti-tumor indications specified in the National Medical Product Administration approved drug package inserts within 2 weeks prior to initiation of administration
* Had major surgery within 4 weeks prior to initiation of medication;
* Other severe, acute, or chronic medical conditions or laboratory abnormalities that, in the investigator's opinion, may increase the risks associated with study participation or may interfere with the interpretation of the study results, or are otherwise unsuitable for participation in the clinical study;
* The compliance of patients to participate in this clinical study is estimated to be insufficient.
18 Years
80 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Weifang People's Hospital
Weifang, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Shugeng Gao, Doctor
Role: primary
Guangyu An, Doctor
Role: primary
Shaohua Ma, Doctor
Role: primary
Nan Wu, Doctor
Role: backup
Zhidong Liu, Doctor
Role: primary
Mingqiang Kang, Doctor
Role: primary
Wei Tan, Doctor
Role: primary
Wentao Fang, Doctor
Role: primary
Xiaofei Zhuang, Doctor
Role: primary
Jun Chen, Doctor
Role: primary
Daqiang Sun, Doctor
Role: primary
Other Identifiers
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TQB2450-II/III-01
Identifier Type: -
Identifier Source: org_study_id