To Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.

Trial Title: To Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.

NCT ID: NCT05859373

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation
Description: TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
Arm group label: TQB3728 tablets+chemoradiation, sequential maintenance with TQB2450 injection

Intervention type: Combination Product
Intervention name: TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation
Description: TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
Arm group label: TQB3728 tablets+chemoradiation, sequential maintenance with TQB3728 tablets and TQB2450 injection

Intervention type: Combination Product
Intervention name: TQB2450 injection, sequential or concurrent chemoradiation
Description: TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
Arm group label: Sequential or concurrent chemoradiation, sequential maintenance with TQB2450 injection.

Summary: It's a Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in sequential maintenance TQB2450 injection therapy in patients after sequential or concurrent chemoradiation for locally advanced non-small cell lung cancer. Incidence and severity of adverse events (AEs), the type of dose-limiting toxicity(ies) (DLT[s]) and Recommended phaseII dose(RP2D) were the Phase Ib primary endpoint. Overall response rate (ORR) was the Phase II primary endpoint.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Between the ages of 18-75 years (calculated based on the date of signing Informed consent form (ICF) ); male or female; - Non resectable stage III non-small cell lung cancer (NSCLC) patients confirmed by histopathological or cytological examination； - At least one measurable lesion (based on RECIST 1.1)； - Has not received any systematic treatment or targeted radiotherapy for locally advanced non-small cell lung cancer; - Eastern cooperative oncology group (ECOG) score 0-1; - Estimated survival time ≥ 3 months; - The main organs function are normally, meeting following criteria: 1. routine blood tests: hemoglobin (HGB) ≥80g/L (no blood transfusion and blood products within 14 days); absolute neutrophil count (ANC) ≥1.5×109/L; platelets (PLT)≥90×10^9/L. 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥ 60 ml/min. 3. Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy); 4. Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%. - Female participants should have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Participants should agree that contraception must be used during the study period and for 6 months after the end of the study. Exclusion Criteria: - Comorbidity and medical history: 1. Have had or currently have other malignant tumors within 2 years. The following two conditions can be enrolled: other malignancies treated with a single surgery; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ) and T1 (tumor-invasive basement membrane)]; 2. Pathological types of mixed small cell and non-small cell lung cancer components； 3. Patients with known EGFR/ALK mutations 4. There was Therapeutic toxicity (≥ CTC AE grade 2 infection) 5. Have a history of idiopathic pulmonary fibrosis, organized pneumonia, drug-induced pneumonia, or idiopathic pneumonia 6. Subjects who have received major surgical treatment or obvious traumatic injury within 4 weeks prior to initial administration - Tumor related symptoms and treatment 1. Received Antitumor traditional Chinese medicine treatment within 2 weeks before the start of research treatment； 2. Previously received other PD-1/PD-L1/CTLA-4 antibody treatments or immunotherapy; 3. Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage; - Research treatment related: 1. Subjects who have received the vaccine within 4 weeks prior to the first dose, or is planning to be vaccinated during the study period 2. Individuals with a previous history of severe allergies to macromolecular drugs or severe hypersensitivity reactions after administration of other monoclonal antibodies 3. Existence of any active autoimmune disease or history of autoimmune disease - Subjects who have participated in clinical trials of other anti-tumor drugs within 4 weeks before the first dose - According to the judgment of the investigator, subjects with concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects with other reasons which are not suitable for inclusion.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Hospital Affiliated to Shandong First Medical University

Address:
City: Jinan
Zip: 250117
Country: China

Contact:
Last name: Yuping Sun, Doctor

Phone: +86 13370582181
Email: 13370582181@163.com

Start date: June 2023

Completion date: December 2024

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/NCT05859373