Status:
UNKNOWN
Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 inserti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04063462
Start Date
October 1 2019
End Date
October 1 2021
Last Update
August 21 2019
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060