Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer

NCT02535507 | Unknown Phase 2 DMC

• 1 other identifier: FK1406
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Keywords

pyrotinib; HER2; Non-small Cell Lung Cancer; Phase II

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib

  tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months

Secondary Outcomes (1)

• Progression Free Survival

  24 months

Other Outcomes (3)

• overall survival

  24 months

• Safety and Tolerability

  24 months

• quality of life (measured by questionnaire)

  24 months

Study Arms (1)

Pyrotinib treatment arm

EXPERIMENTAL

pyrotinib treatment arm

Drug: Pyrotinib

Interventions

Pyrotinib DRUG

Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed

Pyrotinib treatment arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 and ≤80 years.
• ECOG performance status of 0 to 1.
• Life expectancy of more than 12 weeks.
• At least one measurable lesion exists.(RECIST 1.1)
• Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.
• Required laboratory values including following parameters:
• ANC: ≥ 1.5 x 10\^9/L, Platelet count: ≥ 80 x 10\^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: \< 470 ms
• Signed informed consent.

You may not qualify if:

• Subjects with third space fluid that can not be controled by drainage or other methods.
• Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
• Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy
• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
• Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
• Receiving any other antitumor therapy.
• Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
• History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• 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.
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
• Known history of neurological or psychiatric disease, including epilepsy or dementia.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Department of Oncology, Shanghai pulmonary hospital

Shanghai, 200433, China

RECRUITING

Related Publications (2)

• Mao S, Yang S, Liu X, Li X, Wang Q, Zhang Y, Chen J, Wang Y, Gao G, Wu F, Jiang T, Zhang J, Yang Y, Lin X, Zhu X, Zhou C, Ren S. Molecular correlation of response to pyrotinib in advanced NSCLC with HER2 mutation: biomarker analysis from two phase II trials. Exp Hematol Oncol. 2023 Jun 9;12(1):53. doi: 10.1186/s40164-023-00417-y.

  PMID: 37296463 DERIVED

• Wang Y, Jiang T, Qin Z, Jiang J, Wang Q, Yang S, Rivard C, Gao G, Ng TL, Tu MM, Yu H, Ji H, Zhou C, Ren S, Zhang J, Bunn P, Doebele RC, Camidge DR, Hirsch FR. HER2 exon 20 insertions in non-small-cell lung cancer are sensitive to the irreversible pan-HER receptor tyrosine kinase inhibitor pyrotinib. Ann Oncol. 2019 Mar 1;30(3):447-455. doi: 10.1093/annonc/mdy542.

  PMID: 30596880 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pyrotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Caicun Zhou, MD,PhD

  Shanghai Pulmonary Hospital, Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caicun Zhou, MD,PhD

CONTACT

86-65115006-3050; caicunzhoudr@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 28, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

CN (1)