NCT05169801

Brief Summary

This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

January 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

1.7 years

First QC Date

December 23, 2021

Last Update Submit

December 23, 2021

Conditions

Non-small Cell Lung Cancer(NSCLC)

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    optimal ORR at 18 weeks, independent radiographic assessment

    18 weeks

Secondary Outcomes (8)

  • Progression-free survival

    41 months

  • Overall survival (OS)

    41 months

  • Disease Control Rate (DCR)

    41 months

  • Duration of Response (DoR)

    41 months

  • Quality of Life assessment using EORTC QLQ-C30

    41 months

  • +3 more secondary outcomes

Study Arms (2)

Treatment group A

EXPERIMENTAL
Drug: BP102, paclitaxel, carboplatin

Treatment group B

ACTIVE COMPARATOR
Drug: Avastin®, paclitaxel, carboplatin

Interventions

BP102, paclitaxel, carboplatinDRUG

BP102, paclitaxel, carboplatin

Treatment group A
Avastin®, paclitaxel, carboplatinDRUG

Avastin®, paclitaxel, carboplatin

Treatment group B

Eligibility Criteria

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

You may qualify if:

  • Aged from 18 to 75 (including 18 and 75), male or female;
  • Patients with locally advanced and unresectable NSCLC that has been histologically or cytologically proven, metastatic, or recurrent NSCLC.
  • No previous systematic antitumor therapy for current stage diseases. If previous adjuvant therapy has been received, it is necessary to ensure that the interval between the end of adjuvant therapy and the first administration of this study is more than 6 months, and that all adjuvant treating-related toxic reactions have recovered.
  • Patients must be able to document the EGFR mutation and ALK fusion gene status, and ALK must be negative. Patients who have not previously been tested for EGFR and ALK genes should be tested during screening;
  • There must be at least one measurable lesion as a target (according to RECIST V1.1);
  • ECOG: 0\~1;
  • Life expectancy ≥24 weeks;
  • Major organs' function well.

You may not qualify if:

  • Patients with non-small cell lung cancer of other pathological tissue types;
  • Tumor histology or cytology confirmed positive ALK fusion gene;
  • Patients with imaging evidence of tumor invasion of large blood vessels;
  • Patients with uncontrolled pleural effusion and pericardial effusion that require repeated drainage;
  • Patients with abdominal effusion;
  • During the screening period, chest CT showed tumor cavity formation, or CT scan was highly suspected of idiopathic pulmonary fibrosis, mechanized pneumonia, drug-associated pneumonia, idiopathic pneumonia or active pneumonia;
  • Patients with hypertension whose blood pressure has not been satisfactorily controlled by antihypertensive drugs, and patients with previous hypertensive crisis or hypertensive encephalopathy;
  • Have heart disease or clinical symptoms that are not well controlled;
  • Patients with unhealed wounds, active gastric ulcers or fractures;
  • Patients diagnosed with esophagotracheal fistula;
  • People with known hereditary bleeding tendency or coagulation disorder;
  • Patients with known central nervous system metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PaclitaxelCarboplatinBevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: BP102 in combination with paclitaxel/carboplatin compared with Avastin® in combination with paclitaxel/carboplatin
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2021

First Posted

December 27, 2021

Study Start

January 25, 2018

Primary Completion

October 21, 2019

Study Completion

June 17, 2021

Last Updated

December 27, 2021

Record last verified: 2021-12

Locations

CN(1)