To Predict Efficacy by Detecting Circulating Endothelial Cell Subsets and Blood Perfusion Parameters Changes in Vivo Tumor in Study of QL1101 and Avastin® in Patients With Non-squamous Non-small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

To Predict Efficacy by Detecting Circulating Endothelial Cell Subsets and Blood Perfusion Parameters Changes in Vivo Tumor in Study of QL1101 and Avastin® in Patients With Non-squamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03195569
• Other study ID #: QL1101
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2017
• Last updated: June 21, 2017
• Start date: March 1, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: June 2017
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Pilin Ma
• Phone: 0086-531-83126996
• Email: pilin.ma[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the study of QL1101 and Avastin® in patients with Non-squamous Non-small Cell Lung Cancer

Description:

The study is QL1101-002 additional research, by detecting the blood circulating endothelial cells and blood perfusion parameters change within tumors early prediction efficacy and drug resistance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 10, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged =18 years and =75 years;

• Patients with histologically or cytologically confirmed inoperable locally advanced (Stage IIIb, not suitable for multidisciplinary treatment), metastatic (Stage IV), or relapsed non-squamous cell non-small cell lung cancer. Diagnostic result of non-squamous cell non-small cell lung cancer obtained based on sputum cytology should be immunohistochemically confirmed. If a variety of tumor ingredients are mixed, the main cell types should be classified;

• ECOG score of 0-1 points;

• At least one measurable lesion can be evaluated according to RECIST1.1 criteria;

• Patients who have not received systemic anti-tumor therapy of locally advanced or metastatic non-squamous non-small cell lung cancer (if the subject received adjuvant therapy after completing the radical treatment of early non-small cell lung cancer, but then the disease relapsed, the subject can be enrolled. In this case, the end time of the adjuvant therapy is required to be more than 6 months from the time of the first administration of this study, and various toxic reactions resulting from the adjuvant therapy should have recovered (= Grade 1 by CTCAE 4.03 criteria, except for alopecia);

• Expected survival time =24 weeks;

Exclusion Criteria:

• Central squamous cell carcinoma, and mixed gland squamous cell carcinoma with squamous cell as the main ingredient;

• ALK fusion gene is known to be positive;

• Medical history or examination shows thrombotic disease within 6 months prior to screening;

• Imaging shows signs of tumor invasion of large vessels, and the investigator or radiologist must exclude patients whose tumor has been completely close to or surrounded or invaded the lumen of large vessels (e.g., the superior pulmonary artery or superior vena cava);

• Patients with a past history of symptomatic brain metastases or meningeal metastases, or spinal cord compression;

• Patients who received palliative radiotherapy for bone lesions outside the chest within 2 weeks prior to the first dose of the study drug;

• Patients who received major surgical procedures (including thoracotomy), or suffered from major trauma (such as fractures) within 28 days

• prior to screening, or need to undergo major surgery during the expected study treatment period;

• Patients who received a minor surgical procedure within 48 hours prior to the first treatment with Anivitis® QL1101 (the investigator judges whether there is bleeding tendency);

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• QL1101
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
• Avastin®
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
• Paclitaxel
175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.
• Carboplatin
AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tainjin

Sponsors (2)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.	Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	The actual endpoint is best response seen during the study	18 weeks
Primary	Number of circulating endothelial cell subsets	To detect the number of circulating activated endothelial cell (aCECs) by flow cytometry	different time points before and after one week of treatment of QL1101 or avastin, an expected average of 2 weeks
Secondary	The strength of intratumoral blood perfusion index(BV,BF,PS and MTT)	To detect the strength of intratumoral blood perfusion index(BV,BF,PS and MTT) by CT perfusion imaging	different time points before and after 3 weeks of treatment QL1101 or avastin, an expected average of 6 weeks
Secondary	Disease control rate	DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death	3 months, 6 months, 9 months, 1 year
Secondary	Treatment-emergent adverse events	Assessment following therapy with either QL1101 or avastin	18 week