- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03169335
Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer
August 22, 2018 updated by: Qilu Pharmaceutical Co., Ltd.
A Multi-center, Randomized, Double-blind, Parallel, Two-group Phase III Clinical Study of the Efficacy and Safety of QL1101 and Avastin® Respectively Combined With Paclitaxel and Carboplatin in the First-line Treatment of Non-squamous Non-small Cell Lung Cancer
The objective of this study is to assess the similarity between QL1101 and Avastin® respectively combined with chemotherapy in terms of efficacy and safety in patients with non-squamous non-small cell lung cancer.
The study intends to include first-line patients with non-squamous non-small cell lung cancer, and uses QL1101 combined with basic chemotherapy CP (paclitaxel + carboplatin).
The regimen is consistent with the usage and dosage of Avastin® at home and abroad indicated for the treatment of non-squamous non-small cell lung cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study is a randomized, double-blind, positive drug-controlled, multi-center Phase III study.
It is planned to enroll 512 treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC).
Subjects are randomized into the QL1101 combined with paclitaxel/carboplatin or Avastin® combined with paclitaxel/carboplatin treatment group by a ratio of 1:1, and stratified by age (≥65 years, <65 years), sex (male, female) and EGFR subtype (sensitive mutation type, wild type).
Study Type
Interventional
Enrollment (Actual)
535
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China
- Shanghai Chest Hospital
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Tianjin, China
- Tianjin Chest Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged ≥18 years and ≤75 years; 2) 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; Lesions situated in a previously irradiated area are considered measurable only if marked progressive signs occur after irradiation
- 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.
- Subjects must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form.
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);
- Patients who are currently using or have recently used (within 10 days prior to the first dose of Avastin®/QL1101) aspirin (>325 mg/day) or other nonsteroidal antiinflammatory drugs known to inhibit platelet function, or full-dose anticoagulants;
- Patients whose medical history or examination shows hereditary bleeding tendency or coagulation disorders, which may increase the risk of bleeding; -Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg);
- Patients who had a past history of hypertensive crisis or hypertensive encephalopathy;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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 (at least 4 cycles).
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targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle.
Number of cycles 4-6.
AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle.
Number of cycles: 4-6.
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Active Comparator: 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 (at least 4 cycles).
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175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle.
Number of cycles 4-6.
AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle.
Number of cycles: 4-6.
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: 18 weeks
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The actual endpoint is best response seen during the study
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18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate
Time Frame: 3 months, 6 months, 9 months, 1 year
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DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death
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3 months, 6 months, 9 months, 1 year
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Overall survival (OS)
Time Frame: 18 months after enrollment and randomization of the last case
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OS is defined as the time from randomization and grouping to patient death due to various causes.
For patients who are lost to follow-up, the date when they were contacted for the last time will be used as the cut off time.
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18 months after enrollment and randomization of the last case
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Progression-free survival (PFS)
Time Frame: 18 months after enrollment and randomization of the last case
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PFS is defined as the time from randomization and grouping to PD or death.
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18 months after enrollment and randomization of the last case
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Treatment-emergent adverse events
Time Frame: 18 weeks
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Assessment following therapy with either QL1101 or avastin
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18 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2017
Primary Completion (Actual)
June 23, 2018
Study Completion (Actual)
July 13, 2018
Study Registration Dates
First Submitted
May 23, 2017
First Submitted That Met QC Criteria
May 25, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
August 24, 2018
Last Update Submitted That Met QC Criteria
August 22, 2018
Last Verified
May 1, 2017
More Information
Terms related to this study
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
- QL1101-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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