Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Tislelizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Mitogens

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Tyrosine

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.

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.

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

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.

Anlotinib hydrochloride capsule

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

Yuankai Shi, Doctor

Tongmei Zhang, Doctor

DingZhi Huang, Doctor

RunXiang Yang, Doctor

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.

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.

A Phase 3, Randomized, Double-blind, Parallel Controlled, Multi-center Study to Compare the Safety and Efficacy 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 as a First-line Treatment on Patient With Advanced Squamous NSCLC.

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

Overall survival is the time from randomization to the time of death from any cause.

Progression free survival (PFS) assessed by investigators according to The Response Evaluation Criteria In Solid Tumors 1.1 (RECIST) and iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.

Objective response rate (ORR), assessed by investigators according to The Response Evaluation Criteria In Solid Tumors 1.1 (RECIST) and iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.

Disease control rate (DCR)assessed by investigators according to RECIST 1.1 and iRECIST criteria

Duration of response (DOR) assessed by investigators according to RECIST1.1 and iRECIST criteria

The occurrence of adverse events (AEs) is to evaluate safety profile

The severity of adverse events (AEs) is to evaluate safety profile

The occurence of abnormal heart rate is to evaluate safety profile

The severity of abnormal heart rate is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\].

The occurrence rate of abnormal 12 lead ECG is to evaluate safety profile. The results of PR interval were divided into low, normal and high according to the normal value range.

The results of PR interval were divided into low, normal and high according to the normal value range, and the relative baseline change was described with a cross table. The minimum or maximum observed value after the baseline is used to calculate the results after the baseline.

Descriptively summarize the results of PR examination at each visit, classify them as normal, abnormal without clinical significance, and abnormal with clinical significance, and compare them with the results of baseline, and describe them with cross classification table. The severity is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\]

The occurrence of abnormal 12 lead ECG is to evaluate safety profile. The QRS interval results were divided into low, normal and high according to the normal value range.

The QRS interval results were divided into low, normal and high according to the normal value range, and the relative baseline change was described with a cross table. The minimum or maximum observed value after the baseline is used to calculate the results after the baseline.

Descriptively summarize the results of PR examination at each visit, classify them as normal, abnormal without clinical significance, and abnormal with clinical significance, and compare them with the results of baseline, and describe them with cross classification table. The severity is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\]

The occurrence rate of Abnormal 12 lead ECG is to evaluate safety profile. The results of QT interval were divided into low, normal and high according to the normal value.

The results of QT interval were divided into low, normal and high according to the normal value range, and the relative baseline change was described with a cross table. The minimum or maximum observed value after the baseline is used to calculate the results after the baseline.

Descriptively summarize the results of PR examination at each visit, classify them as normal, abnormal without clinical significance, and abnormal with clinical significance, and compare them with the results of baseline, and describe them with cross classification table. The severity is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\]

The occurrence of Abnormal 12 lead ECG is to evaluate safety profile. The results of QTc interval were divided into low, normal and high according to the normal value.

The results of QTc interval were divided into low, normal and high according to the normal value range, and the relative baseline change was described with a cross table. The minimum or maximum observed value after the baseline is used to calculate the results after the baseline.

Descriptively summarize the results of PR examination at each visit, classify them as normal, abnormal without clinical significance, and abnormal with clinical significance, and compare them with the results of baseline, and describe them with cross classification table. The severity is evaluated in accordance with the standard of common toxic reactions of the National Cancer Institute \[NCI CTC v5.0\]

The occurrence of serious adverse events (SAEs) is to evaluate safety profile

The severity of serious adverse events (SAEs) is to evaluate safety profile

QLQ-C30 is a quality of life questionnaire to help understand the physical condition of the subjects. The subjects need to answer them in person and circle the number that best reflects their situation. Among them, 1 represents no, 2 represents a little, 3 represents some, and 4 represents a lot. Questions 29 and 30 need to choose the most suitable number from 1 to 7 and draw a circle. The other 1 represents very poor, and 7 represents very good. Questions 29 and 30 need to choose the most suitable number from 1 to 7 and draw a circle. The other 1 represents very poor, and 7 represents very good.

QLQ-LC13 is a quality of life questionnaire to help understand the physical condition of the subjects. The subjects need to answer them in person and circle the number that best reflects their situation. Among them, 1 represents no, 2 represents a little, 3 represents some, and 4 represents a lot.

EQ-5D assessment pro is a quality of life questionnaire, which has five questions that need to be answered by the subjects themselves, choose the answer that best reflects their health, and mark the point on the set scale that best represents their health, of which 100 represents the best condition and 0 represents the worst condition.

It's a parameter to evaluate the immunogenicity of TQB2450 injection

Spots Global Cancer Trial Database for 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.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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