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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

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ClinicalTrials.gov Identifier: NCT03195569
Recruitment Status : Unknown
Verified June 2017 by Qilu Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Tianjin Medical University Cancer Institute and Hospital
Information provided by (Responsible Party):
Qilu Pharmaceutical Co., Ltd.

Brief 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

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 12, 2018
Estimated Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: 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.




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 18 weeks ]
    The actual endpoint is best response seen during the study

  2. Number of circulating endothelial cell subsets [ Time Frame: different time points before and after one week of treatment of QL1101 or avastin, an expected average of 2 weeks ]
    To detect the number of circulating activated endothelial cell (aCECs) by flow cytometry


Secondary Outcome Measures :
  1. The strength of intratumoral blood perfusion index(BV,BF,PS and MTT) [ Time Frame: different time points before and after 3 weeks of treatment QL1101 or avastin, an expected average of 6 weeks ]
    To detect the strength of intratumoral blood perfusion index(BV,BF,PS and MTT) by CT perfusion imaging

  2. Disease control rate [ Time Frame: 3 months, 6 months, 9 months, 1 year ]
    DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death

  3. Treatment-emergent adverse events [ Time Frame: 18 week ]
    Assessment following therapy with either QL1101 or avastin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195569


Contacts
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Contact: Pilin Ma 0086-531-83126996 pilin.ma@qilu-pharma.com

Locations
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China
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tainjin, China
Contact: Kai Li    0086-22-81351613    likai5@medmail.com.cn, likqupp@yahoo.com   
Principal Investigator: Kai Li, Professor         
Sponsors and Collaborators
Qilu Pharmaceutical Co., Ltd.
Tianjin Medical University Cancer Institute and Hospital

Additional Information:

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Responsible Party: Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03195569     History of Changes
Other Study ID Numbers: QL1101
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

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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
Keywords provided by Qilu Pharmaceutical Co., Ltd.:
QL1101 Avastin® Non Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors