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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.

Tracking Information
First Submitted Date  ICMJE March 5, 2019
First Posted Date  ICMJE March 7, 2019
Last Update Posted Date July 9, 2020
Estimated Study Start Date  ICMJE December 2020
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Progression-free survival [ Time Frame: up to approximately 16 months ]
Progression-free survival evaluated by Blinded Independent Center Review
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Progression-free survival [ Time Frame: up to approximately 16 months ]
    Progression-free survival evaluated by investigators
  • Objective response rate [ Time Frame: up to approximately 16 months ]
    Objective response rate
  • Best objective response [ Time Frame: up to approximately 16 months ]
    Best objective response
  • Disease control rate [ Time Frame: up to approximately 16 months ]
    Disease control rate
  • Duration of response [ Time Frame: up to approximately 16 months ]
    Duration of response
  • Overall survival [ Time Frame: up to approximately 30 months ]
    Overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE
  • Drug: BPI-7711
    180 mg, oral, QD
    Other Name: BPI-7711 capsule
  • Drug: Gefitinib
    250 mg, oral, QD
    Other Name: Iressa
  • Drug: Placebo Tablet
    250 mg gefitinib placebo tablet, QD
    Other Name: placebo
  • Drug: Placebo capsule
    180 mg BPI-7711 placebo capsule, QD
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: BPI-7711
    180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD
    Interventions:
    • Drug: BPI-7711
    • Drug: Placebo Tablet
  • Active Comparator: Gefitinib
    180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD
    Interventions:
    • Drug: Gefitinib
    • Drug: Placebo capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
294
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wenxiang Lu +86 021-62165501 wenxiang.lu@betapharma.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03866499
Other Study ID Numbers  ICMJE BPI-7711301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Beta Pharma, Inc.
Study Sponsor  ICMJE Beta Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuankai Shi Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRS Account Beta Pharma, Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP