Clinical Trials /

Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation

NCT04063462

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: PEER20
  • NCT ID: NCT04063462

Conditions

  • Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
PyrotinibCohort 1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1ExperimentalPreviously treated patients with EGFR exon 20 insertion mutant positive NSCLC
  • Pyrotinib
Cohort 2ExperimentalPreviously treated patients with HER2 exon 20 insertion mutant positive NSCLC
  • Pyrotinib

Eligibility Criteria

        Inclusion Criteria:

          1. 18-80years,ECOG PS:0-2,Life expectancy of more than 3 months,with measurable lesion (
             RECIST1.1).

          2. Histologically or cytologic confirmed EGFR or HER2 Exon 20 Insertion Mutation positive
             advanced Non-small cell lung cancer who failed prior therapies.

          3. ≥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.

          4. Main organs function is normal.

          5. Signed and dated informed consent.

        Exclusion Criteria:

          1. 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

          2. 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

          3. With kinds of factors which affect oral medicine (e.g. failing to swallow,
             gastrointestinal tract getting resected, chronic diarrhea and ileus)

          4. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry

          5. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to Pyrotinib

          6. 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

          7. 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

          8. Known history of neurological or psychiatric disease, including epilepsy or dementia

          9. 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

         10. Respiratory syndrome (dyspnea≥CTC AE 2), severe pleural effusion, ascites, pericardial
             effusion

         11. 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

         12. 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

         13. Patient is pregnant or breast-feeding

         14. Judgment by the investigator that should not participate in the study if the patient
             is unlikely to comply with study procedures, restrictions and requirements
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate
Time Frame:To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:24 months
Safety Issue:
Description: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"
Measure:Disease Control Rate (DCR)
Time Frame:24 months
Safety Issue:
Description:Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).
Measure:OS(Overall Survival)
Time Frame:24 months
Safety Issue:
Description: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.
Measure:Duration of Response (DoR)
Time Frame:24 months
Safety Issue:
Description: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.
Measure:Safety and Tolerability
Time Frame:24 months
Safety Issue:
Description:Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Tianjin Medical University Cancer Institute and Hospital

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