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A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT03866499
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Beta Pharma, Inc.

Study Description
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Brief Summary:
A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR mutation

Condition or disease Intervention/treatment Phase
NSCLC Drug: BPI-7711 Drug: Gefitinib Drug: Placebo Tablet Drug: Placebo capsule Phase 3

Detailed Description:
This is a Phase III clinical study, which aims to compare the efficacy and safety of BPI-7711 capsule and gefitinib tablet in the treatment of initially-treated patients with locally advanced or recurrent metastatic with EGFR mutation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of BPI-7711 Capsule in Locally Advanced or Recurrent/Metastatic Treatment-naïve Non-small Cell Lung Cancer Patients With EGFR Mutation
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: BPI-7711
180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD
 Drug: BPI-7711
180 mg, oral, QD
Other Name: BPI-7711 capsule

Drug: Placebo Tablet
250 mg gefitinib placebo tablet, QD
Other Name: placebo
Active Comparator: Gefitinib
180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD
 Drug: Gefitinib
250 mg, oral, QD
Other Name: Iressa

Drug: Placebo capsule
180 mg BPI-7711 placebo capsule, QD
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to approximately 16 months ]
    Progression-free survival evaluated by Blinded Independent Center Review


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to approximately 16 months ]
    Progression-free survival evaluated by investigators

  2. Objective response rate [ Time Frame: up to approximately 16 months ]
    Objective response rate

  3. Best objective response [ Time Frame: up to approximately 16 months ]
    Best objective response

  4. Disease control rate [ Time Frame: up to approximately 16 months ]
    Disease control rate

  5. Duration of response [ Time Frame: up to approximately 16 months ]
    Duration of response

  6. Overall survival [ Time Frame: up to approximately 30 months ]
    Overall survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer.
  • The ECOG score of performance status is 0-1.
  • Locally advanced or recurrent metastatic NSCLC that has never received systemic treatment.
  • According to RECIST1.1 criteria, there is at least 1 measurable lesion that has not been previously irradiated.
  • Prior to enrollment, a central laboratory testing report has confirmed that the tumor has one of two common EGFR mutations positive that are sensitive to EGFR-TKI therapy, accompanied with or not accompanied with other EGFR mutation, with the exception of exon 20 insertion.

Exclusion Criteria:

  • Previously received systemic treatment for locally advanced or recurrent metastatic cancer.
  • Primary T790M mutation-positive patient.
  • Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormonal therapy, or any clinically proven active interstitial lung disease.
  • Known active infections such as hepatitis B, hepatitis C, and human immunodeficiency virus.
  • Local radiation therapy is carried out within 1 week; more than 30% bone marrow radiation therapy or extensive radiation therapy is performed within 4 weeks.
  • ≤ 4 weeks from major surgery or ≤ 2 weeks from minor surgery.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866499


Contacts
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Contact: Wenxiang Lu +86 021-62165501 wenxiang.lu@betapharma.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100021
Contact: Yuankai Shi, PhD         
Contact: Puyuan Xing, PhD         
Principal Investigator: Yuankai Shi, PhD         
China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China
Contact: Xingya Li         
China, Shandong
Linyi Cancer Hospital Recruiting
Linyi, Shandong, China
Contact: Jianhua Shi         
Sponsors and Collaborators
Beta Pharma, Inc.
Investigators
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Principal Investigator: Yuankai Shi Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: Beta Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03866499    
Other Study ID Numbers: BPI-7711301
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beta Pharma, Inc.:
EGFR
T790M
NSCLC
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action