Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Recurrence

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

SIBP04, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.

SIBP04

Avastin, 15mg/kg, intravenous infusion, the first intravenous infusion 90min (+10min), 3 weeks/cycle, administered on the first day of each treatment cycle.

Avastin

Paclitaxel, 175mg/m2, intravenous infusion, every 3 weeks/cycle, administered on the first day of each treatment cycle.

Carboplatin, AUC=5.0, (upper limit 800mg), intravenous infusion, 3 weeks/cycle, administered on the first day of each treatment cycle.

Yuankai Shi, Doctor

Aidong Qu, Master

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. To evaluate the clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

This trial is a randomized, double-blind, parallel-controlled, multicenter phase III clinical study. The study was divided into three stages: screening stage, treatment stage (combined chemotherapy stage, single drug maintenance treatment stage, visit after treatment) and follow-up stage (survival follow-up after disease progression). To evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of SIBP04 in patients with locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer.

This is a randomized, double-blind, parallel-controlled, multicenter Phase III clinical study.

A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer

A Randomized, Double-blind, Parallel-controlled Study Comparing the Efficacy and Safety of Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (SIBP04) and Bevacizumab Injection (Avastin) in Combination With Paclitaxel and Carboplatin Respectively in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer.

Total number of any spontaneously reported and all directly observed adverse events.

That is serious adverse events, any serious adverse events that occurred to the subject during the study period.

Evaluate the immunogenicity of the SIBP04 group and the bevacizumab group.

The trough concentration is a pharmacokinetic evaluation index.

ORR is defined as the best ORR from the first medication to the 18th week, initially evaluated by the investigator, and finally evaluated by a third-party independent blinded imaging, including cases of complete response (CR) and partial response (PR).

PFS is defined as the time between randomization and disease progression or death(The date when event happened first).

OS is defined as the time between randomization and patient death from all causes, with the date of last contact as the cut-off date if the patient is lost to follow-up.

DOR is defined as the time from the first evaluation of a tumor as CR or PR to the first evaluation of disease progression or death.

DCR was defined as the percentage of the total evaluable cases with remission or disease stabilization after treatment (That is, cases of CR, PR and stable disease(SD)).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer	NCT05318443	Non-squamous No...	SIBP04 Avastin Paclitaxel Carboplatin	18 Years - 75 Years	Shanghai Institute Of Biological Products
A Study Exploring Efficacy of SIBP04 in Subjects With Non-squamous Non-small Cell Lung Cancer	NCT05318443	Non-squamous No...	SIBP04 Avastin Paclitaxel Carboplatin	18 Years - 75 Years	Shanghai Institute Of Biological Products

Spots Global Cancer Trial Database for sibp04

Every month we try and update this database with for sibp04 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sibp04

Every month we try and update this database with for sibp04 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sibp04 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.