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

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3728 tablets+chemoradiation, sequential maintenance with TQB2450 injection

TQB3728 tablets combined with sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4\~6 cycles, sequential maintenance therapy of TQB2450 injection.

Group Type: EXPERIMENTAL

TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation

Intervention Type: COMBINATION_PRODUCT

TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

TQB3728 tablets+chemoradiation, sequential maintenance with TQB3728 tablets and TQB2450 injection

TQB3728 tablets combined with sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4\~6 cycles, sequential maintenance with TQB3728 tablets and TQB2450 injection for 4 cycles. Then sequential maintenance with TQB2450 injection monotherapy；

Group Type: EXPERIMENTAL

TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation

Intervention Type: COMBINATION_PRODUCT

TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

Sequential or concurrent chemoradiation, sequential maintenance with TQB2450 injection.

Sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4\~6 cycles, sequential maintenance with TQB2450 injection；

Group Type: ACTIVE_COMPARATOR

TQB2450 injection, sequential or concurrent chemoradiation

Intervention Type: COMBINATION_PRODUCT

TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

Interventions

TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation

TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

Intervention Type: COMBINATION_PRODUCT

TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation

TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

Intervention Type: COMBINATION_PRODUCT

TQB2450 injection, sequential or concurrent chemoradiation

TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Countries

China

Facility Contacts

Yuping Sun, Doctor

Role: primary

13370582181@163.com

+86 13370582181

Other Identifiers

TQB3728-Ib/II-02

Identifier Type: -

Identifier Source: org_study_id