Description:
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.
Title
- Brief Title: 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
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
QL1101-002
- NCT ID:
NCT03169335
Conditions
- Non-squamous Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
QL1101 | | Experimental group |
Avastin® | bevacizumab | Control group |
Paclitaxel | | Control group |
Carboplatin | | Control group |
Purpose
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.
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental group | Experimental | 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). | - QL1101
- Paclitaxel
- Carboplatin
|
Control group | Active Comparator | 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). | - Avastin®
- Paclitaxel
- Carboplatin
|
Eligibility Criteria
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;
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate |
Time Frame: | 18 weeks |
Safety Issue: | |
Description: | The actual endpoint is best response seen during the study |
Secondary Outcome Measures
Measure: | Disease control rate |
Time Frame: | 3 months, 6 months, 9 months, 1 year |
Safety Issue: | |
Description: | DOR is defined as the time from the first tumor evaluation as CR or PR to the first evaluation as PD or death |
Measure: | Overall survival (OS) |
Time Frame: | 18 months after enrollment and randomization of the last case |
Safety Issue: | |
Description: | 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. |
Measure: | Progression-free survival (PFS) |
Time Frame: | 18 months after enrollment and randomization of the last case |
Safety Issue: | |
Description: | PFS is defined as the time from randomization and grouping to PD or death. |
Measure: | Treatment-emergent adverse events |
Time Frame: | 18 weeks |
Safety Issue: | |
Description: | Assessment following therapy with either QL1101 or avastin |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Qilu Pharmaceutical Co., Ltd. |
Last Updated
August 24, 2018