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

Non-squamous Non-small Cell Lung Cancer Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT03169335
• Other study ID #: QL1101-002
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2017
• Est. completion date: July 13, 2018

Study information

• Verified date: May 2017
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: July 13, 2018
• Est. primary completion date: June 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-squamous Non-small Cell Lung Cancer

Intervention

Drug:
• QL1101
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
• Avastin®
targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
• Paclitaxel
175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle. Number of cycles 4-6.
• Carboplatin
AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle. Number of cycles: 4-6.

Locations

Country	Name	City	State
China	Shanghai Chest hospital	Shanghai
China	Tianjin Chest hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	The actual endpoint is best response seen during the study	18 weeks
Secondary	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	3 months, 6 months, 9 months, 1 year
Secondary	Overall survival (OS)	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.	18 months after enrollment and randomization of the last case
Secondary	Progression-free survival (PFS)	PFS is defined as the time from randomization and grouping to PD or death.	18 months after enrollment and randomization of the last case
Secondary	Treatment-emergent adverse events	Assessment following therapy with either QL1101 or avastin	18 weeks