NSCLCPhase 3NCT03866499
A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
A Phase 3 study testing BPI-7711 and Gefitinib in people with NSCLC, run by Beta Pharma Shanghai at 3 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- BPI-7711 and Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 3 sitesChina
- Study dates
- 30 Apr 2021to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Linyi Cancer Hospital
Linyi, Shandong
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPI-7711Drug
Also called BPI-7711 capsule
180 mg, oral, QD
GefitinibDrug
Also called Iressa
250 mg, oral, QD
Placebo TabletDrug
Also called placebo
250 mg gefitinib placebo tablet, QD
Placebo capsuleDrug
Also called placebo
180 mg BPI-7711 placebo capsule, QD
| Study group | Role | What they receive |
|---|---|---|
| BPI-7711 | Experimental | 180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD Receives: Drug: BPI-7711; Drug: Placebo Tablet |
| Gefitinib | Active comparator | 180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD Receives: Drug: Gefitinib; Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival evaluated by Blinded Independent Center Review
Measured: up to approximately 16 months
Secondary outcomes (6)
Progression-free survival
Progression-free survival evaluated by investigators
Measured: up to approximately 16 months
Objective response rate
Objective response rate
Measured: up to approximately 16 months
Best objective response
Best objective response
Measured: up to approximately 16 months
Disease control rate
Disease control rate
Measured: up to approximately 16 months
Duration of response
Duration of response
Measured: up to approximately 16 months
Overall survival
Overall survival
Measured: up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start30 Apr 2021
- Primary completion30 Nov 2023
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beta Pharma Shanghai
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866499
- Sponsor's protocol ID
- BPI-7711301
- Status last verified
- Aug 2024
- First submitted
- 5 Mar 2019
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 41924561Shi 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03866499
- Acronym / sponsor ID
- BPI-7711301
- Conditions
- NSCLC
- Keywords
- EGFR mutation, EGFR TKI, NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Beta Pharma ShanghaiIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPI-7711 | Experimental | Drug: BPI-7711, Drug: Placebo Tablet180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD |
| Gefitinib | Active comparator | Drug: Gefitinib, Drug: Placebo capsule180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPI-7711Also: BPI-7711 capsule180 mg, oral, QD | Drug | BPI-7711 |
| GefitinibAlso: Iressa250 mg, oral, QD | Drug | Gefitinib |
| Placebo TabletAlso: placebo250 mg gefitinib placebo tablet, QD | Drug | BPI-7711 |
| Placebo capsuleAlso: placebo180 mg BPI-7711 placebo capsule, QD | Drug | Gefitinib |
Primary outcome
Progression-free survival
Time frame: up to approximately 16 months
Progression-free survival evaluated by Blinded Independent Center Review
6 secondary outcomes
Progression-free survival
Time frame: up to approximately 16 months
Objective response rate
Time frame: up to approximately 16 months
Best objective response
Time frame: up to approximately 16 months
Disease control rate
Time frame: up to approximately 16 months
Duration of response
Time frame: up to approximately 16 months
Overall survival
Time frame: up to approximately 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 41924561Yang 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.
- Derived from this study: PubMed 39914443Shi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BPI-7711 and Gefitinib in people with NSCLC, run by Beta Pharma Shanghai at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: up to approximately 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866499, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.