Trial Title:
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
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2450 injection + Chemotherapy
Description:
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1
(PD-L1).
Chemotherapy is a systematic treatment that kill fast growing cells.
Arm group label:
TQB2450 injection + Chemotherapy
Intervention type:
Drug
Intervention name:
TQB2450 injection + Anlotinib Hydrochloride Capsule
Description:
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1
(PD-L1).
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Arm group label:
TQB2450 injection + Anlotinib Hydrochloride Capsule
Summary:
This is a clinical study on the efficacy and safety of TQB2450 injection combined with
chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of
resectable non-small cell lung cancer. The part I study was planned to enroll 58
subjects, 1:1 randomized into two cohorts. The treatment regimen was as follows: Cohort
1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6
weeks after the last administration, and TQB2450 therapy should be continued for 1 year
after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib
hydrochloride capsule. Surgery was performed 4-6 weeks after the last dose and continued
for 1 year starting 4 weeks after surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- patients with stage II-IIIB (T3N2M0 only) Non-Small Cell Lung Carcinoma (NSCLC) and
determined to be eligible for curable R0 excision, after pathologic diagnosis of
puncture specimens;
- ≥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:
- Present or complication with other malignancies within 5 years.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital of Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Shugeng Gao, Doctor
Phone:
+86 13901362568
Email:
13901362568@139.com
Facility:
Name:
Beijing Chaoyang Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100027
Country:
China
Status:
Recruiting
Contact:
Last name:
Guangyu An, Doctor
Phone:
+86 13811831430
Email:
agybjcy@163.com
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Shaohua Ma, Doctor
Phone:
+86 15611963506
Email:
doctormsh@163.com
Contact backup:
Last name:
Nan Wu, Doctor
Phone:
+86 13910154426
Email:
nanwu@bjmu.edu.cn
Facility:
Name:
Beijing Chest Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
101149
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhidong Liu, Doctor
Phone:
+86 13601338599
Email:
lzdzrd@sina.com
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingqiang Kang, Doctor
Phone:
+86 18805900101
Email:
kangmingqiang@sina.com
Facility:
Name:
Weifang People's Hospital
Address:
City:
Weifang
Zip:
261044
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Tan, Doctor
Phone:
+86 13863659099
Email:
13863659099@126.com
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wentao Fang, Doctor
Phone:
+86 13901867516
Email:
vwffang@hotmail.com
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaofei Zhuang, Doctor
Phone:
+86 13393402808
Email:
lieutenant79@163.com
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300070
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jun Chen, Doctor
Phone:
+86 15822192921
Email:
huntercj2004@qq.com
Facility:
Name:
Tianjin Chest Hospital
Address:
City:
Tianjin
Zip:
300222
Country:
China
Status:
Recruiting
Contact:
Last name:
Daqiang Sun, Doctor
Phone:
+86 13034337758
Email:
sdqmd@163.com
Start date:
June 14, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05913089
