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

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

Tracking Information

• First Submitted Date: March 5, 2019
• First Posted Date: March 7, 2019
• Last Update Posted Date: July 9, 2020
• Estimated Study Start Date: December 2020
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: NSCLC

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 5, 2019): 294
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2023
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03866499
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Beta Pharma, Inc.
• Study Sponsor: Beta Pharma, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yuankai Shi; Cancer Institute and Hospital, Chinese Academy of Medical Sciences

• PRS Account: Beta Pharma, Inc.
• Verification Date: July 2020