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NSCLCPhase 2NCT03812809

A Phase IIb Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients With T790M Mutation Positive

A Phase 2 study testing BPI-7711 in people with NSCLC, run by Beta Pharma Shanghai at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711 capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR mutation and T790M mutation positive. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
3 sitesChina
Study dates
5 Jul 2019to 24 Jan 2022
Phase
Phase 2
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

  • Aged at least 18 years.
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
  • Radiological documentation of disease progression after the most recent EGFR-TKI treatment administered. Radiological documentation of disease progression after the most recent treatment, or intolerant to current chemotherapy, or unwilling to accept the current treatment.
  • At least one non-brain measurable lesion, not previously irradiated that can be accurately measured at baseline. If only one measurable lesion, the baseline CT should be performed before the biopsy or at least 14 days after the biopsy. Prior irradiated lesion can only be used as biopsy lesion after significant progression.
  • Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).
  • Patients must have central confirmation of tumor T790M mutation+ status from a biopsy sample or a plasma sample taken after confirmation of disease progression on the most recent EGFR-TKI treatment. Primary T790M mutation positive patients should provide prior written evidence before ICF signature and have not received any EGFR-TKI.
  • ECOG performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
  • Females of child-bearing potential using contraception and must have a negative pregnancy test.

Who cannot join

  • Confirmed EGFR 20 exon insertion mutation after the initial diagnosis of NSCLC.
  • Treatment with any 1st or 2nd EGFR-TKI (eg, erlotinib, gefitinib, icotinib, afatinib or dacomitinib) within 5x half-life of study entry.
  • Treatment with any 3rd generation EGFR TKIs target on T790M mutation.
  • Treatment with any cytotoxic chemotherapy, investigational agents, CYP3A4/CYP2C19 potent inhibitor/inducer, or other anticancer drugs within 14 days of study entry.
  • Prior medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
  • Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to study treatment.
  • Major surgery within 4 weeks of study entry; radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of study entry.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases or bowel resection.

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

Other trials in China

About this study

Official title: A Phase IIb, Open-label, Single-arm Study to Assess the Safety and Efficacy of BPI-7711 Capsule in Patients With Metastatic or Recurrent Non-small Cell Lung Cancer With EGFR Mutation and T790M Mutation Positive.

A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711 capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR mutation and T790M mutation positive.

Read the detailed description

This is a phase IIb, open-label, single arm study assessing the safety and efficacy of BPI-7711 (180 mg, orally, once daily) in China with a confirmed diagnosis of EGFR sensitizing mutation positive and T790M mutation+ unresectable, locally advanced or metastatic NSCLC, who have progressed on prior EGFR-TKIs treatment. The primary objective of the study is to assess the efficacy of BPI-7711 by assessment of ORR according to RECIST 1.1 by an Independent Central Review.

Conditions
NSCLC
Being tested
BPI-7711
Keywords
EGFR, T790M, NSCLC

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

    BPI-7711: 180mg, QD, oral

Study groups in NCT03812809
Study groupRoleWhat they receive
BPI-7711ExperimentalBPI-7711: 180mg, QD, oral
Receives: Drug: BPI-7711

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR according to RECIST 1.1 by an Independent Central Review (ICR)

    Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

    Measured: up to 52 weeks

Secondary outcomes (3)

  1. ORR according to RECIST 1.1 by investigators

    Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

    Measured: up to 52 weeks

  2. Disease control rate (DCR) according to RECIST 1.1

    DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.

    Measured: up to 104 weeks

  3. Progression free survival(PFS) according to RECIST 1.1

    PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from BPI-7711 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.

    Measured: up to 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start5 Jul 2019
  3. Primary completion24 Jan 2022
  4. Study completion24 Jan 2022

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03812809
Sponsor's protocol ID
BPI-7711201
Status last verified
May 2022
First submitted
18 Jan 2019
Last updated
19 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yang S, Wu S, Zhao Y, Chen G, Zhu B, Li X, Wang K, Shi J, Cang S, Yao W, Fan Y, Fang J, Zhang L, Zhou J, Wu L, Zheng R, Huang M, Pan Y, Yang Z, Sun M, Yu H, Wang D, Huang J, Wang L, Shu Y, Chen Z, Liu C, Li J, Liu J, Sun S, Guo Y, Meng Z, Liu Z, Han Z, Wu G, Lu H, Ma R, Hu S, Zhao G, Zhang L, Liu Z, Xie C, Zhong D, Zhao H, Bi M, Yi S, Guo S, Yi T, Li W, Lin Y, Chen Z, Zhuang Z, Guo Z, Greco M, Wang T, Zhou A, Shi Y. Central nervous system efficacy of rezivertinib (BPI-7711) in advanced NSCLC patients with EGFR T790M mutation: A pooled analysis of two clinical studies. Lung Cancer. 2023 Jun;180:107194. doi: 10.1016/j.lungcan.2023.107194. Epub 2023 Apr 17.

    PubMed 37163774

  • Shi Y, Wu S, Wang K, Cang S, Yao W, Fan Y, Wu L, Huang M, Li X, Pan Y, Yang Z, Zhu B, Chen G, Shi J, Sun M, Fang J, Wang L, Chen Z, Liu C, Li J, Liu J, Sun S, Zhao Y, Guo Y, Meng Z, Liu Z, Han Z, Lu H, Ma R, Hu S, Zhao G, Liu Z, Xie C, Zhong D, Zhao H, Yu H, Zhang L, Bi M, Yi S, Guo S, Yi T, Li W, Lin Y, Shu Y, Chen Z, Guo Z, Greco M, Wang T, Shen H. Efficacy and Safety of Rezivertinib (BPI-7711) in Patients With Locally Advanced or Metastatic/Recurrent EGFR T790M-Mutated NSCLC: A Phase 2b Study. J Thorac Oncol. 2022 Nov;17(11):1306-1317. doi: 10.1016/j.jtho.2022.08.015. Epub 2022 Aug 29.

    PubMed 36049654

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BPI-7711 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 19 May 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

ORR according to RECIST 1.1 by an Independent Central Review (ICR) (time frame: up to 52 weeks). 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 NCT03812809, 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 19 May 2022.

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