- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04063462
Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation
August 19, 2019 updated by: Tianjin Medical University Cancer Institute and Hospital
A Phase 2 Study of Pyrotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), With at Least One Prior Systemic Treatment, Locally Advanced or Metastatic, With EGFR or ERBB2 Exon 20 Insertion Mutation (PEER20)
This is a Phase 2, open-label study to evaluate the efficacy and the safety/tolerability of pyrotinib in previously treated NSCLC patients with EGFR exon 20 insertion mutations or HER2 exon 20 insertion mutations.
Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dingzhi Huang, Doctor
- Phone Number: 3200 86-22-23340123
- Email: dingzhih72@163.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Tianjin Medical University Cancer Institute and Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-80years,ECOG PS:0-2,Life expectancy of more than 3 months,with measurable lesion ( RECIST1.1).
- Histologically or cytologic confirmed EGFR or HER2 Exon 20 Insertion Mutation positive advanced Non-small cell lung cancer who failed prior therapies.
- ≥1 target lesion that has not received radiotherapy in the past 3 months and can be accurately measured in at least 1 direction;Previously received radiation therapy, but the radiotherapy area must be <25% of the bone marrow area, and radiation therapy must have closed for at least≥4 weeks at the time of enrollment.
- Main organs function is normal.
- Signed and dated informed consent.
Exclusion Criteria:
- Patient has had previous treatment with Pyrotinib, Poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible
- Patients who planned to receive systemic anti-tumor therapy within 4 weeks prior to allocation or during the course of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or receiving the Mitomycin C 6 weeks prior to medication). Extra-field radiotherapy (EF-RT) was performed 4 weeks prior to allocation or restricted radiotherapy for assessing tumor lesions within 2 weeks prior to allocation
- With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
- Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pyrotinib
- History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation; active infection including hepatitis B (HBV DNA level ≥1000 copies /mL), hepatitis C and human immunodeficiency virus (HIV); Severe acute or chronic infections requiring systemic treatment
- Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial
- Known history of neurological or psychiatric disease, including epilepsy or dementia
- Has a history of malignant tumors. Except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer who have undergone curative treatment and have no disease recurrence within 5 years after the start of treatment
- Respiratory syndrome (dyspnea≥CTC AE 2), severe pleural effusion, ascites, pericardial effusion
- Abnormal blood coagulation (INR>1.5 or PT > ULN + 4s or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; Renal insufficiency: urinary protein ≥ ++, or 24-hour urine protein ≥ 1.0g
- Patient has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully treated and stable early stage prostate cancer or carcinoma in situ of the cervix or breast without need of treatment
- Patient is pregnant or breast-feeding
- Judgment by the investigator that should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cohort 1
Previously treated patients with EGFR exon 20 insertion mutant positive NSCLC
|
pyrotinib, single agent, 400mg p.o once daily until disease progressed
|
EXPERIMENTAL: Cohort 2
Previously treated patients with HER2 exon 20 insertion mutant positive NSCLC
|
pyrotinib, single agent, 400mg p.o once daily until disease progressed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
|
The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of pyrotinib to the end of study.
|
To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response (DoR)
Time Frame: 24 months
|
Number of days from the date that measurement criteria are first met for CR or PR (whichever status is recorded first) until the first subsequent date that progressive disease or death is documented.
|
24 months
|
Progression Free Survival
Time Frame: 24 months
|
The PFS time is defined as time from enrollment to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of : "death", "last tumor assessment", "last follow up date" or "last date in drug log"
|
24 months
|
Disease Control Rate (DCR)
Time Frame: 24 months
|
Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).
|
24 months
|
OS(Overall Survival)
Time Frame: 24 months
|
OS was defined as time from date of enrollment to date of death due to any cause.
For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.
|
24 months
|
Safety and Tolerability
Time Frame: 24 months
|
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2019
Primary Completion (ANTICIPATED)
April 1, 2021
Study Completion (ANTICIPATED)
October 1, 2021
Study Registration Dates
First Submitted
July 21, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (ACTUAL)
August 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 21, 2019
Last Update Submitted That Met QC Criteria
August 19, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEER20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individul participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion
IPD Sharing Access Criteria
Data access requests will be reviewed by an external indepentent Review Panel.
Requestors will be required to sign a Data Access Agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
Clinical Trials on Pyrotinib
-
Hunan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruitingHER2-positive Breast CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesCompleted
-
Peking Union Medical CollegeUnknownBreast Cancer | HER2 Gene MutationChina
-
Tongji UniversityUnknownNon-small Cell Lung CancerChina
-
Henan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Active, not recruitingMetastatic Breast CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.UnknownNon Small Cell LungChina
-
RemeGen Co., Ltd.Not yet recruitingNon-small Cell Lung CancerChina
-
Second Affiliated Hospital, School of Medicine,...Zhejiang Cancer Hospital; First Affiliated Hospital of Zhejiang University; Sir... and other collaboratorsUnknownColorectal CancerChina
-
The First Affiliated Hospital with Nanjing Medical...First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
-
Hengrui Therapeutics, Inc.UnknownBreast Cancer | Gastric Cancer | NSCLC | Solid TumorsUnited States