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Status unknownNCT03866499Updated Aug 7, 2024

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

A Phase 3 interventional study of BPI-7711 and Gefitinib in NSCLC, sponsored by Beta Pharma Shanghai. Status unknown at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Beta Pharma Shanghai · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
369
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • NSCLC

Keywords

  • EGFR mutation
  • EGFR TKI
  • NSCLC
03

In context

Lead sponsor

Beta Pharma Shanghai is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
369 participants (actual)

Study arms

  • Experimental
    BPI-7711

    180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD

    Drug: BPI-7711 · Drug: Placebo Tablet

  • Active comparator
    Gefitinib

    180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD

    Drug: Gefitinib · Drug: Placebo capsule

Interventions

  • DrugBPI-7711

    180 mg, oral, QD

    Also known as: BPI-7711 capsule

  • DrugGefitinib

    250 mg, oral, QD

    Also known as: Iressa

  • DrugPlacebo Tablet

    250 mg gefitinib placebo tablet, QD

    Also known as: placebo

  • DrugPlacebo capsule

    180 mg BPI-7711 placebo capsule, QD

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Progression-free survival evaluated by Blinded Independent Center Review

    Time frame: up to approximately 16 months

Secondary outcomes

  1. Progression-free survival

    Progression-free survival evaluated by investigators

    Time frame: up to approximately 16 months

  2. Objective response rate

    Objective response rate

    Time frame: up to approximately 16 months

  3. Best objective response

    Best objective response

    Time frame: up to approximately 16 months

  4. Disease control rate

    Disease control rate

    Time frame: up to approximately 16 months

  5. Duration of response

    Duration of response

    Time frame: up to approximately 16 months

  6. Overall survival

    Overall survival

    Time frame: up to approximately 30 months

07

Study locations

3 sites
  • Cancer Hospital Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 100021, China
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
  • Linyi Cancer Hospital
    Linyi, Shandong, China
08

References and documents

Publications

  • Yang S, Zhao Y, Sun M, Bi M, Zhu B, Chen Z, Yu H, Zhang L, Wu L, Zhou R, Yao W, Li X, Han Z, Wang K, Wang L, Wen M, Guo Y, Lin Y, Sun S, Guo S, Yi T, Zhao W, Yu Z, Qin J, Pan Y, He Z, Ye F, Shi H, Fang J, Ma R, Lu H, Zhang H, Shi J, Gao J, Cui J, Li M, Yi S, Cang S, Shu Y, Zhang D, Peng J, Gao F, Wang T, Zhou A, Shi Y. Rezivertinib in EGFR-Mutated Non-Small Cell Lung Cancer Patients with Central Nervous System Metastasis: Central Nervous System Efficacy from the Phase III REZOR Study. Cancer Commun (Lond). 2026 Mar 31;46:0018. doi: 10.34133/cancomm.0018. eCollection 2026. PubMed 41924561 ↗
  • Shi Y, Guo Y, Li X, Wu L, Chen Z, Yang S, Bi M, Zhao Y, Yao W, Yu H, Wang K, Zhao W, Sun M, Zhang L, He Z, Lin Y, Shi J, Zhu B, Wang L, Pan Y, Shi H, Sun S, Wen M, Zhou R, Guo S, Han Z, Yi T, Zhang H, Cang S, Yu Z, Zhong D, Cui J, Fang J, Gao J, Li M, Ma R, Jiang M, Qin J, Shu Y, Ye F, Hu S, Li W, Lu H, Yang M, Yi S, Zhang Y, Fan Y, Ji H, Liu Z, Wang H, Zhou X, Zhang D, Peng J, Shen H, Gao F, Wang T, Zhou A. Rezivertinib versus gefitinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (REZOR): a multicentre, double-blind, randomised, phase 3 study. Lancet Respir Med. 2025 Apr;13(4):327-337. doi: 10.1016/S2213-2600(24)00417-X. Epub 2025 Feb 3. PubMed 39914443 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03866499
Lead sponsor
Beta Pharma Shanghai
Responsible party
Sponsor
First posted
Mar 7, 2019
Start date
Apr 30, 2021
Primary completion
Nov 30, 2023
Completion
Dec 30, 2025 (estimated)
Last update
Aug 7, 2024

Study contacts

Yuankai Shi
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Rezivertinib

Other studies from this sponsor

Beta Pharma Shanghai

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