Non Small Cell Lung CancerNCT03195569
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
An observational study of Non Small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- QL1101, Avastin® and Paclitaxel
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 10 Dec 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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);
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tainjin
Kai Li, 0086-22-81351613, likai5@medmail.com.cn, likqupp@yahoo.com
Kai Li, Professor
About this study
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
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- QL1101, Avastin®, Paclitaxel, Carboplatin
- Keywords
- QL1101 Avastin® Non Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1101Drug
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
Avastin®Drug
Also called bevacizumab
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
PaclitaxelDrug
175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.
CarboplatinDrug
AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: QL1101; Drug: Paclitaxel; Drug: 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. Receives: Drug: Avastin®; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The actual endpoint is best response seen during the study
Measured: 18 weeks
Number of circulating endothelial cell subsets
To detect the number of circulating activated endothelial cell (aCECs) by flow cytometry
Measured: 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)
To detect the strength of intratumoral blood perfusion index(BV,BF,PS and MTT) by CT perfusion imaging
Measured: different time points before and after 3 weeks of treatment QL1101 or avastin, an expected average of 6 weeks
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
Measured: 3 months, 6 months, 9 months, 1 year
Treatment-emergent adverse events
Assessment following therapy with either QL1101 or avastin
Measured: 18 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start1 Mar 2017
- Primary completion12 Jun 2018 (estimated)
- Study completion10 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195569
- Sponsor's protocol ID
- QL1101
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03195569
- Acronym / sponsor ID
- QL1101
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- QL1101 Avastin® Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 12 Jun 2018 (estimated)
- Study completion
- 10 Dec 2018 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Drug: QL1101, Drug: Paclitaxel, Drug: CarboplatinQL1101 + 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. |
| Control group | – | Drug: Avastin®, Drug: Paclitaxel, Drug: CarboplatinAvastin® + 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1101targeted vascular endothelial growth factor (VEGF) monoclonal antibodies | Drug | Experimental group |
| Avastin®Also: bevacizumabtargeted vascular endothelial growth factor (VEGF) monoclonal antibodies | Drug | Control group |
| Paclitaxel175 mg/m2, IV following investigational product on day 1 of each 21 day cycle. | Drug | Control group, Experimental group |
| CarboplatinAUC 5 IV, following paclitaxel on day 1 of each 21 day cycle. | Drug | Control group, Experimental group |
Primary outcome
Objective response rate
Time frame: 18 weeks
The actual endpoint is best response seen during the study
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
3 secondary outcomes
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
Disease control rate
Time frame: 3 months, 6 months, 9 months, 1 year
Treatment-emergent adverse events
Time frame: 18 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pilin Ma (0086-531-83126996, pilin.ma@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.