NCT03812809

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2.6 years

First QC Date

January 18, 2019

Last Update Submit

May 13, 2022

Conditions

NSCLC

Keywords

EGFRT790MNSCLC

Outcome Measures

Primary Outcomes (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.

    up to 52 weeks

Secondary Outcomes (3)

  • ORR according to RECIST 1.1 by investigators

    up to 52 weeks

  • Disease control rate (DCR) according to RECIST 1.1

    up to 104 weeks

  • Progression free survival(PFS) according to RECIST 1.1

    up to 104 weeks

Study Arms (1)

BPI-7711

EXPERIMENTAL

BPI-7711: 180mg, QD, oral

Drug: BPI-7711

Interventions

BPI-7711DRUG

BPI-7711: 180mg, QD, oral

Also known as: BPI-7711 capsule
BPI-7711

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Linyi Cancer Hospital

Linyi, Shandong, China

Location

Related Publications (2)

  • 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.

    PMID: 37163774DERIVED

  • 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.

    PMID: 36049654DERIVED

MeSH Terms

Interventions

rezivertinib

Study Officials

  • Yuankai Shi

    National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 23, 2019

Study Start

July 5, 2019

Primary Completion

January 24, 2022

Study Completion

January 24, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)