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A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQB2450 injection + Chemotherapy
TQB2450 injection + Anlotinib Hydrochloride Capsule
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital of Chinese Academy of Medical SciencesRecruiting
  • Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
  • Beijing Cancer HospitalRecruiting
  • Beijing Chest Hospital, Capital Medical University
  • Fujian Medical University Union HospitalRecruiting
  • Weifang People's HospitalRecruiting
  • Shanghai Chest Hospital
  • Shanxi Cancer HospitalRecruiting
  • Tianjin Medical University General Hospital
  • Tianjin Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TQB2450 injection + Chemotherapy

TQB2450 injection + Anlotinib Hydrochloride Capsule

Arm Description

TQB2450 injection combined with chemotherapy, 21 days as a treatment cycle.

TQB2450 injection combined with anlotinib hydrochloride capsule, 21 days as a treatment cycle.

Outcomes

Primary Outcome Measures

Major pathologic response (MPR)
MPR defined as the percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery.

Secondary Outcome Measures

Overall survival (OS)
From randomization to the time of death from any cause.
2/3 year OS rate
The ratio of two-year survival to three-year survival.
Event free survival (EFS) assessed by the investigator.
From the time of randomization to the occurrence of a predetermined event, including death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc.
Disease free survival (DFS) assessed by Blinded Independent Central Review (BICR)
The time from randomization to the onset of tumor recurrence or death from any cause.
Pathological complete response (pCR)
Ratio of patients with no residual cancer cells found in the pathological examination after treatment.
R0 resection rate
The proportion of subjects who could undergo R0 resection, which is one of the surgery-related end points.
Surgical delay rate
The proportion of subjects who could not undergo surgery in time after neoadjuvant therapy.
Pathological downgrading rate
The proportion of patients with reduced lung cancer stage determined by pathological results after surgery.

Full Information

First Posted
June 13, 2023
Last Updated
June 27, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05913089
Brief Title
A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer
Official Title
A Phase II/III Clinical Study on the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Perioperative Treatment of Resectable Stage II/III Non Small Cell Lung Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQB2450 injection + Chemotherapy
Arm Type
Experimental
Arm Description
TQB2450 injection combined with chemotherapy, 21 days as a treatment cycle.
Arm Title
TQB2450 injection + Anlotinib Hydrochloride Capsule
Arm Type
Experimental
Arm Description
TQB2450 injection combined with anlotinib hydrochloride capsule, 21 days as a treatment cycle.
Intervention Type
Drug
Intervention Name(s)
TQB2450 injection + Chemotherapy
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
TQB2450 injection + Anlotinib Hydrochloride Capsule
Intervention Description
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Primary Outcome Measure Information:
Title
Major pathologic response (MPR)
Description
MPR defined as the percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery.
Time Frame
Baseline up to 60 months.
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
From randomization to the time of death from any cause.
Time Frame
Baseline up to 60 months.
Title
2/3 year OS rate
Description
The ratio of two-year survival to three-year survival.
Time Frame
Baseline up to 36 months.
Title
Event free survival (EFS) assessed by the investigator.
Description
From the time of randomization to the occurrence of a predetermined event, including death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc.
Time Frame
Baseline up to 60 months.
Title
Disease free survival (DFS) assessed by Blinded Independent Central Review (BICR)
Description
The time from randomization to the onset of tumor recurrence or death from any cause.
Time Frame
Baseline up to 60 months.
Title
Pathological complete response (pCR)
Description
Ratio of patients with no residual cancer cells found in the pathological examination after treatment.
Time Frame
Baseline up to 4 months.
Title
R0 resection rate
Description
The proportion of subjects who could undergo R0 resection, which is one of the surgery-related end points.
Time Frame
Baseline up to 4 months.
Title
Surgical delay rate
Description
The proportion of subjects who could not undergo surgery in time after neoadjuvant therapy.
Time Frame
Baseline up to 4 months.
Title
Pathological downgrading rate
Description
The proportion of patients with reduced lung cancer stage determined by pathological results after surgery.
Time Frame
Baseline up to 4 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shugeng Gao, Doctor
Phone
+86 13901362568
Email
13901362568@139.com
Facility Information:
Facility Name
Cancer Hospital of Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shugeng Gao, Doctor
Phone
+86 13901362568
Email
13901362568@139.com
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangyu An, Doctor
Phone
+86 13811831430
Email
agybjcy@163.com
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaohua Ma, Doctor
Phone
+86 15611963506
Email
doctormsh@163.com
First Name & Middle Initial & Last Name & Degree
Nan Wu, Doctor
Phone
+86 13910154426
Email
nanwu@bjmu.edu.cn
Facility Name
Beijing Chest Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhidong Liu, Doctor
Phone
+86 13601338599
Email
lzdzrd@sina.com
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingqiang Kang, Doctor
Phone
+86 18805900101
Email
kangmingqiang@sina.com
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Tan, Doctor
Phone
+86 13863659099
Email
13863659099@126.com
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wentao Fang, Doctor
Phone
+86 13901867516
Email
vwffang@hotmail.com
Facility Name
Shanxi Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofei Zhuang, Doctor
Phone
+86 13393402808
Email
lieutenant79@163.com
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Chen, Doctor
Phone
+86 15822192921
Email
huntercj2004@qq.com
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daqiang Sun, Doctor
Phone
+86 13034337758
Email
sdqmd@163.com

12. IPD Sharing Statement

Learn more about this trial

A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer

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