A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer
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.
1 other identifier
interventional
58
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2023
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedStudy Start
First participant enrolled
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 29, 2023
December 1, 2022
3 years
June 13, 2023
June 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Major pathologic response (MPR)
MPR defined as the percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery.
Baseline up to 60 months.
Secondary Outcomes (8)
Overall survival (OS)
Baseline up to 60 months.
2/3 year OS rate
Baseline up to 36 months.
Event free survival (EFS) assessed by the investigator.
Baseline up to 60 months.
Disease free survival (DFS) assessed by Blinded Independent Central Review (BICR)
Baseline up to 60 months.
Pathological complete response (pCR)
Baseline up to 4 months.
- +3 more secondary outcomes
Study Arms (2)
TQB2450 injection + Chemotherapy
EXPERIMENTALTQB2450 injection combined with chemotherapy, 21 days as a treatment cycle.
TQB2450 injection + Anlotinib Hydrochloride Capsule
EXPERIMENTALTQB2450 injection combined with anlotinib hydrochloride capsule, 21 days as a treatment cycle.
Interventions
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 is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100027, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Weifang People's Hospital
Weifang, Shandong, 261044, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300070, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2023
First Posted
June 22, 2023
Study Start
June 14, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 29, 2023
Record last verified: 2022-12