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.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.10 sites in 1 country58 target enrollmentJune 14, 2023

ConditionsNon Small Cell Lung Cancer

InterventionsTQB2450 injection + Anlotinib Hydrochloride Capsule TQB2450 injection + Chemotherapy

DrugsTQB2450 injection + Chemotherapy TQB2450 injection + Anlotinib Hydrochloride Capsule

Overview

Phase: Phase 2
Intervention: TQB2450 injection + Anlotinib Hydrochloride Capsule
Conditions: Non Small Cell Lung Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 58
Locations: 10
Primary Endpoint: Major pathologic response (MPR)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 14, 2023

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

TQB2450 injection + Anlotinib Hydrochloride Capsule

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

Intervention: TQB2450 injection + Anlotinib Hydrochloride Capsule

TQB2450 injection + Chemotherapy

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

Intervention: TQB2450 injection + Chemotherapy

Outcomes

Primary Outcomes

Major pathologic response (MPR)

Time Frame: Baseline up to 60 months.

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

Secondary Outcomes

2/3 year OS rate(Baseline up to 36 months.)
Surgical delay rate(Baseline up to 4 months.)
Pathological complete response (pCR)(Baseline up to 4 months.)
Disease free survival (DFS) assessed by Blinded Independent Central Review (BICR)(Baseline up to 60 months.)
Overall survival (OS)(Baseline up to 60 months.)
Event free survival (EFS) assessed by the investigator.(Baseline up to 60 months.)
Pathological downgrading rate(Baseline up to 4 months.)
R0 resection rate(Baseline up to 4 months.)