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A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

A Phase III Study Comparing Efficacy and Safety of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

NCT03533127•Luye Pharma Group Ltd.

View on ClinicalTrials.gov

Summary

This is a Randomized, Double-blind, Multicenter Phase III Study Comparing Efficacy and Safety of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Bevacizumab Combined with Paclitaxel and Carboplatin for Treatment of Naïve Subjects with Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

Detailed Description

The objectives are to compare the efficacy, safety and immunogenicity of LY01008 and bevacizumab combined with paclitaxel and carboplatin for treatment of subjects with metastatic or recurrent nonsquamous non-small cell lung cancer. The subjects will receive the treatment with LY01008 or bevacizumab combined with paclitaxel and carboplatin for 4-6 cycles, and then both groups of subjects will receive the maintenance monotherapy with LY01008 until occurrence of progressive disease (PD), intolerable toxicity reaction, withdrawal of informed consent, loss to follow-up, death, conduct of other antineoplastic therapy or completion of the whole study. The doses of LY01008 and bevacizumab are 15 mg/kg in combination therapy. The dose of LY01008 in maintenance monotherapy is 15 mg/kg.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject has voluntarily signed the written informed consent form (ICF)
•Male or female patients aged 18 to 75 years (18 years and 75 years are inclusive)
•The patients with metastatic (stage IV) or recurrent nonsquamous NSCLC proved by histological or cytological demonstrated who cannot have surgical treatment. The diagnosis result of nonsquamous NSCLC obtained only based on the sputum cytology is not accepted. If the patient has many kinds of tumor components, the main cell types should be classified；
•The patient should have at least one measurable lesion as the target lesion (according to RECIST 1.1 criteria)；
•The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 1 point.
•The predictable survival duration is ≥ 6 months
•Laboratory results during screening:
•Blood routine: white blood cell count ≥ 3.0× 109/L, absolute neutrophil count ≥ 1.5× 109/L, platelet count≥ 100× 109/L and hemoglobin≥ 90 g/L.
•Liver function: Total bilirubin \<1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5×ULN for the subjects without liver metastasis and ALT and AST\< 5×ULN for the subjects with liver metastasis.
•Kidney function: Serum creatinine ≤ 1.5 ×ULN or creatinine clearance rate ≥ 50 mL/min and urine protein \<2+ ( quantitative test for 24h urine protein should be conducted when the baseline urine protein is 2+ and the subject can only be enrolled when the 24 h urine protein quantitation is ≤ 1 g );
+3 more criteria

Exclusion Criteria

•The patients who have received chemotherapy or other systemic antineoplastic therapy drugs (such monoclonal antibodies and tyrosine kinase inhibitors) for the disease of the current stage (stage IV or recurrent disease). The patients are allowed to have received past surgery and radiotherapy, but they must meet the criteria for the related two treatment methods listed in the study protocol. The subjects who have recurrented after adjuvant/ neoadjuvant chemotherapy can also be enrolled if the interval between the completion time of the adjuvant/ neoadjuvant therapy and the administration time of the initial dose of the study is more than 6 months；
•The subjects with mixed NSCLC which containing small cell cancer component or the squamous-cell carcinoma component dominant；
•The patient has history of hemoptysis within 3 months before screening and the expectorated fresh blood is ≥ 2.5 mL.
•The images reveal sign of tumor invasion in great vessels. The subjects with tumor completely closes to, surrounds or invades the lumen of great vessels (such as pulmonary artery or superior vena cava) must be excluded;
•The subjects with symptomatic brain metastasis, a history of spinal cord compression or meningeal metastases and subjects who have previously received brain metastasis treatment, if their lesion is radiographically confirmed to have remained stable for more than 4 weeks at screening, can be enrolled；
•The subjects who have received radical thoracic radiotherapy within 28 days before enrollment and the subjects who have received palliative radiotherapy for the bone lesions besides chest within 2 weeks before the treatment with the first dose of study drugs；
•The subjects who have had major surgery, major trauma (such as fracture) within 28 days before randomization or the subjects who are expected to have major surgery during the study cycle ；
•The patients who are taking or have taken aspirin (\>325 mg/day) or other non-steroidal anti-inflammatory drugs which are known to be able to inhibit platelet function recently (within 10 days before receiving the initial dose of the study drugs)；
•The patients who are taking or have taken whole dose oral or parenteral anticoagulation drugs or thrombolytic agents recently (within 10 days before receiving the initial dose of the study drugs). However, the patients are allowed to have preventive use of anticoagulation drugs；
•The patients who have inherited bleeding tendency or coagulation disorders；
+15 more criteria

Locations (1)

Chinese Academy of Medical Sciences

Chaoyang, Beijing Municipality, China

Key Dates

Start Date

November 27, 2017

Primary Completion Date

June 28, 2020

Completion Date

December 28, 2020

Last Updated

July 10, 2018

Enrollment

648

ESTIMATED participants

Conditions

Non Small Cell Lung CancerNon Small Cell Lung Cancer MetastaticNon Small Cell Lung Cancer Recurrent

Interventions

LY01008

DRUG

Bevacizumab

DRUG

Contacts

Can Wu

CONTACT

13811253790 wucan@luye.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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