NCT03195569

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

June 20, 2017

Last Update Submit

June 21, 2017

Conditions

Non Small Cell Lung Cancer

Keywords

QL1101 Avastin® Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • The strength of intratumoral blood perfusion index(BV,BF,PS and MTT)

    different time points before and after 3 weeks of treatment QL1101 or avastin, an expected average of 6 weeks

  • Disease control rate

    3 months, 6 months, 9 months, 1 year

  • Treatment-emergent adverse events

    18 week

Study Arms (2)

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: QL1101Drug: PaclitaxelDrug: Carboplatin

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®Drug: PaclitaxelDrug: Carboplatin

Interventions

QL1101DRUG

targeted vascular endothelial growth factor (VEGF) monoclonal antibodies

Experimental group
Avastin®DRUG

targeted vascular endothelial growth factor (VEGF) monoclonal antibodies

Also known as: bevacizumab
Control group
PaclitaxelDRUG

175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.

Control groupExperimental group
CarboplatinDRUG

AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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;

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tainjin, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

BevacizumabPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Central Study Contacts

Pilin Ma

CONTACT

0086-531-83126996pilin.ma@qilu-pharma.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 22, 2017

Study Start

March 1, 2017

Primary Completion

June 12, 2018

Study Completion

December 10, 2018

Last Updated

June 22, 2017

Record last verified: 2017-06

Locations

CN(1)