A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation (NCT02834936) | Clinical Trial Compass
CompletedPhase 2
A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
China60 participantsStarted 2016-10-20
Plain-language summary
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients of advanced pre-treated Non-small cell lung cancer With HER2 Mutation.
To observe objective response rate (ORR) of pyrotinib in NSCLC With HER2 Mutation. To observe Progression free survival (PFS). To assess the overall survival (OS).
A secondary aim is to obtain safety information.
To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ECOG performance status of 0 to 1.
. Life expectancy of more than 3 months.
. At least one measurable lesion exists.(RECIST 1.1).
. Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to IASLC 2009.
. Failed prior therapies.(RECIST 1.1).
. Confirmed HER2 mutation by Central Laboratory。
. More than one prior Platinum based chemotherapy for advanced and/or metastatic, or recurrent NSCLC in neoadjuvant or adjuvant chemotherapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: tumor assessment every 6-9 weeks after the initiation of pyrotinib, up to 24 months
. Required laboratory values including following parameters:
Exclusion criteria
. Previous therapy with other HER2 inhibitors.
. History of severe hypersensitivity reactions to the excipients of the trial drugs.
. Have clinically significant cavity effusion,such as pleural effusion、 pericardial effusion or ascites and require clinical intervention
. Active brain metastases
. Other malignancy within the past (including primary brain tumor or Leptomeningeal tumor), other than basal cell skin cancer or carcinoma in situ of the cervix
. Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1)
. Treatment with surgery, chemotherapy, radiotherapy or other target therapy within the past 4 weeks before start of therapy