Clinical Trials /

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

NCT03169335

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
QL1101Experimental group
Avastin®bevacizumabControl group
PaclitaxelExperimental group
CarboplatinExperimental 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

NameTypeDescriptionInterventions
Experimental groupExperimentalQL1101 + 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 groupActive ComparatorAvastin® + 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:Recruiting
Lead Sponsor:Qilu Pharmaceutical Co., Ltd.

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