A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03866499 |
Recruitment Status :
Recruiting
First Posted : March 7, 2019
Last Update Posted : July 9, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
NSCLC | Drug: BPI-7711 Drug: Gefitinib Drug: Placebo Tablet Drug: Placebo capsule | Phase 3 |
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 |

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 |
- Progression-free survival [ Time Frame: up to approximately 16 months ]Progression-free survival evaluated by Blinded Independent Center Review
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Wenxiang Lu | +86 021-62165501 | wenxiang.lu@betapharma.com |
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 |
Principal Investigator: | Yuankai Shi | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
EGFR T790M NSCLC |
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 |