TQB2450 Injection Combined With Chemotherapy Followed by Sequential Combination With Anlotinib Hydrochloride Capsule for First-line Treatment of Advanced Squamous Non-small Cell Lung Cancer.

NCT05718167 | Unknown Phase 3

• 1 other identifier: TQB2450-III-12
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 4

Brief Summary

This is Phase 3, randomized, double-blind, parallel controlled study designed to evaluate the Progression Free Survive (PFS) of TQB2450 injection combined with Paclitaxel Injection and Carboplatin Injection Followed by TQB2450 injection combined with Anlotinib Hydrochloride Capsules versus Tislelizumab injection combined with Paclitaxel Injection and Carboplatin Injection followed by Tislelizumab injection in locally advanced (stage ⅢB/ⅢC) and metastatic or recurrent (Stage IV) squamous NSCLC subjects.The primary endpoint is PFS assessed by IRC.

Conditions

Advanced Squamous Non-Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression Free Survival (PFS) assessed by Independent Review Committee (IRC)

  Base line up to 2 years. The curative effect was evaluated every 6 weeks (42 days) in the first 54 weeks of treatment period; After 54 weeks, the efficacy was evaluated every 9 weeks (63 days).

Secondary Outcomes (24)

• Overall survival (OS)

  Baseline up to death event, assessed up to 2 years.

• Progression free survival (PFS)

  From randomization to Progression disease, assessed up to 2 years.

• Objective response rate (ORR)

  From randomization to Progression disease, assessed up to 2 years.

• Disease control rate (DCR)

  From randomization to Progression disease, assessed up to 2 years.

• Duration of response (DOR)

  From randomization to Progression disease, assessed up to 2 years.

Study Arms (2)

TQB2450 Injection and Anlotinib Hydrochloride Capsules

EXPERIMENTAL

In the induction stage: TQB2450 injection: 1200 mg, Intravenous drip on d1; Carboplatin injection: Area Under Curve 5mg/mL/min, Intravenous drip on d1; Paclitaxel injection: 175mg/m2, Intravenous drip on d1. The above schemes are repeated every three weeks. In the maintenance stage: TQB2450 injection: 1200 mg, Intravenous drip on d1; Anlotinib Hydrochloride Capsules: 10mg, orally administered every day from d1-d14. The above schemes are repeated every three weeks.

Drug: TQB2450; Drug: Anlotinib hydrochloride capsule

Tislelizumab Injection

ACTIVE COMPARATOR

In the induction stage: Tislelizumab injection: 200 mg, Intravenous drip; Carboplatin injection: Area Under Curve 5mg/mL/min, Intravenous drip; Paclitaxel injection: 175mg/m2, Intravenous drip. The above schemes are repeated every three weeks. In the maintenance stage: Tislelizumab injection: 200 mg, Intravenous drip on d1 Placebo capsule: 0mg, orally administered every day from d1-d14. The above schemes are repeated every three weeks.

Drug: Tislelizumab injection

Interventions

TQB2450 DRUG

TQB2450 is a humanized monoclonal antibody targeting the programmed death ligand 1 (PD-L1), which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, making T cells recover their activity, thereby enhancing the immune response.

TQB2450 Injection and Anlotinib Hydrochloride Capsules

Anlotinib hydrochloride capsule DRUG

Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor, which can target angiogenesis related kinases, such as VEGFR 1/2/3, FGFR 1/2/3 and other tumor cell proliferation related kinases like Platelet-derived growth factor receptor (PDGFR) α/β、 C-kit, RET.

TQB2450 Injection and Anlotinib Hydrochloride Capsules

Tislelizumab injection DRUG

Tislelizumab injection can bind to human programmed cell death 1 (PD-1), a cell membrane protein that is mainly expressed on activated T cells and inhibits T cell activation.

Tislelizumab Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to the 8th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, the Tumour, node and metastasis (TNM) staging of lung cancer is locally advanced (stage ⅢB/ⅢC), metastatic or recurrent ( Stage IV) NSCLC patients.
• Between the ages of 18-75 years (calculated based on the date of signing ICF); male or female; Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥ 3 months.
• According to the RECIST 1.1 standard, there is at least one measurable lesion. If the measurable lesion is located in the radiotherapy area, it should be clearly defined as a progressive state.
• Patients who have not received systemic anti-tumor therapy for advanced, recurrent or metastatic diseases in the past. For those who have received adjuvant chemotherapy in the past, the interval between the recurrence time and the last adjuvant chemotherapy should be at least 6 months; The interval between the end of previous radiotherapy for chest and this treatment should be more than 6 months, and the interval between palliative radiotherapy for chest and this treatment should be more than 7 days.
• Tumor tissue sections that have not undergone radiotherapy at or after the diagnosis of advanced or metastatic NSCLC must be provided.These are Used for PD-L1 expression detection.Tumor tissue samples must be archived samples or freshly obtained samples within 12 months before randomization.
• main organ function is good, meet the following standards.
• Routine blood examination standards (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days before screening):
• Absolute neutrophil count (ANC) ≥1.5×109 /L;
• Platelets ≥100×109 /L;
• Hemoglobin ≥90 g/L.
• The blood biochemical examination shall meet the following standards:
• Total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN) (Patients with Gilbert syndrome ≤ 3 × ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN. If it is accompanied by liver metastasis, ALT and AST≤5×ULN;
• Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance estimated by Cockcroft-Gault glomerular filtration formula ≥60 mL/min;
• Serum albumin (ALB) ≥30g/L.

You may not qualify if:

• Tumor disease and medical history:
• Brain metastasis exists before enrollment. Subjects meeting one of the following requirements can be included;
• Have received brain metastasis treatment (surgery/radiotherapy) in the past and meet all the following criteria:
• only supratentorial metastasis and cerebellar metastasis,
• the condition needs to be stable for ≥ 2 weeks and no imaging evidence of new brain metastasis or brain metastasis expansion is found;
• there is no brain metastasis symptom, and the subject must have stopped using corticosteroids/dehydrators for at least 2 weeks before starting to use the trial drug;
• The patient has not received brain metastasis treatment in the past and meets all the following criteria:
• the maximum diameter of the lesion is less than 2cm;
• the condition needs to be stable for ≥ 2 weeks (no imaging evidence of new brain metastasis or expanded brain metastasis is found), and there is no neurological symptoms caused by brain tissue compression;
• the subject must have stopped using corticosteroids/dehydrating agents for at least 2 weeks before starting to use the test drug;
• There are midbrain, pons, medulla oblongata, spinal cord and meningeal metastases；
• Other malignant tumors appeared or were present within 3 years. The following two cases can be included: other malignant tumors treated by single operation have achieved 5-year Disease-free survival (DFS) in a row; The cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non-invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• Central type, cavity squamous cell carcinoma (primarily in the main bronchus and around the hilar);Imaging shows that the tumor invades large blood vessels or is unclearly separated from the blood vessels, or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the subsequent study(The major vessels in the chest include pulmonary aorta, left pulmonary artery, right pulmonary artery, four pulmonary veins, superior vena cava, inferior vena cava and aorta);
• There is spinal cord compression and/or severe bone injury caused by tumor bone metastasis, including pathological fracture and severe bone pain with poor control;
• Patients with serous cavity (thoracic cavity, abdominal cavity, or pericardial cavity) that require repeated drainage to relieve clinical symptoms (as determined by the investigator), or who have received drainage of serous cavity effusion for the purpose of treatment within 2 weeks before treatment.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (4)

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, Beijing Municipality, 100021, China

Location

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

TianJin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location

MeSH Terms

Interventions

tislelizumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: February 14, 2023

Record last verified: 2022-04

Locations

CN (4)