NCT03169335

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
Last Updated

August 24, 2018

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

May 23, 2017

Last Update Submit

August 22, 2018

Conditions

Non-squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    The actual endpoint is best response seen during the study

    18 weeks

Secondary Outcomes (4)

  • Disease control rate

    3 months, 6 months, 9 months, 1 year

  • Overall survival (OS)

    18 months after enrollment and randomization of the last case

  • Progression-free survival (PFS)

    18 months after enrollment and randomization of the last case

  • Treatment-emergent adverse events

    18 weeks

Study Arms (2)

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).

Drug: QL1101Drug: PaclitaxelDrug: 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).

Drug: Avastin®Drug: PaclitaxelDrug: Carboplatin

Interventions

QL1101DRUG

targeted vascular endothelial growth factor (VEGF) monoclonal antibodies

Experimental group
Avastin®DRUG

targeted vascular endothelial growth factor (VEGF) monoclonal antibodies

Also known as: bevacizumab
Control group
PaclitaxelDRUG

175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle. Number of cycles 4-6.

Control groupExperimental group
CarboplatinDRUG

AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle. Number of cycles: 4-6.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Chest hospital

Shanghai, China

Location

Tianjin Chest hospital

Tianjin, China

Location

MeSH Terms

Interventions

BevacizumabPaclitaxelCarboplatin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 30, 2017

Study Start

March 28, 2017

Primary Completion

June 23, 2018

Study Completion

July 13, 2018

Last Updated

August 24, 2018

Record last verified: 2017-05

Locations

CN(2)