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

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

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: QL1101; Drug: Avastin®; Drug: Paclitaxel; Drug: Carboplatin

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• China
  • Tainjin, China
    • Recruiting
    • Tianjin Medical University Cancer Institute and Hospital
    • Principal Investigator: Kai Li, Professor
    • Contact: Kai Li; Phone Number: 0086-22-81351613; Email: likai5@medmail.com.cn, likqupp@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients with Non-squamous Non-small Cell Lung Cancer,who should meet the eligibility criteria.Because the study is QL1101-002 additional research, all people meet QL1101-002 clinical research requirements

Description

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);

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; QL1101 + paclitaxel/carboplatin:subjects are given 15 mg/kg QL1101 on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles.	Drug: QL1101; targeted vascular endothelial growth factor (VEGF) monoclonal antibodies; Drug: Paclitaxel; 175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.; Drug: Carboplatin; AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle.
Control group; Avastin® + paclitaxel/carboplatin:subjects are given 15 mg/kg Avastin® on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles.	Drug: Avastin®; targeted vascular endothelial growth factor (VEGF) monoclonal antibodies; Other Names: bevacizumab; Drug: Paclitaxel; 175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.; Drug: Carboplatin; AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	The actual endpoint is best response seen during the study	18 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Treatment-emergent adverse events	Assessment following therapy with either QL1101 or avastin	18 week

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Collaborators: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): June 12, 2018
• Study Completion (Anticipated): December 10, 2018

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: QL1101 Avastin® Non Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Bevacizumab
• Other Study ID Numbers: QL1101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No