Non-small Cell Lung CancerPhase 2NCT02535507
Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Pyrotinib in people with Non-small Cell Lung Cancer, run by Tongji University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, Shanghai pulmonary hospital
Shanghai, 200433
Caicun zhou, MD, PhD, 86-65115006-3050, caicunzhoudr@126.com
shengxiang Ren, MD,PhD, harry_ren@126.com
About this study
Official title: Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Pyrotinib as a Single Agent in HER2 Mutation Advanced Non-small Cell Lung Cancer Patients Who Failed to Previous at Least 2nd Line Treatments
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.
Read the detailed description
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.
To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Pyrotinib
- Keywords
- pyrotinib, HER2, Non-small Cell Lung Cancer, Phase II
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib treatment arm | Experimental | pyrotinib treatment arm Receives: Drug: Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
Measured: tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months
Secondary outcomes (1)
Progression Free Survival
PFS is evaluated in 24 months since the treatment began
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Tongji University
- Investigators
- Caicun Zhou, MD,PhD, Principal investigator, Shanghai Pulmonary Hospital, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535507
- Sponsor's protocol ID
- FK1406
- Status last verified
- Aug 2015
- First submitted
- 25 Aug 2015
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37296463Wang 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.
PubMed 30596880
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Pyrotinib as a Single Agent in HER2 Mutation Advanced Non-small Cell Lung Cancer Patients Who Failed to Previous at Least 2nd Line Treatments
- ClinicalTrials.gov ID
- NCT02535507
- Acronym / sponsor ID
- FK1406
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- pyrotinib, HER2, Non-small Cell Lung Cancer, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.
To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib treatment arm | Experimental | Drug: Pyrotinibpyrotinib treatment arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyrotinibDrug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed | Drug | Pyrotinib treatment arm |
Primary outcome
Objective Response Rate
Time frame: tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months
To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
1 secondary outcome
Progression Free Survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
- Derived from this study: PubMed 37296463Mao 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.
- Derived from this study: PubMed 30596880Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caicun Zhou, MD,PhD principal investigator
Shanghai Pulmonary Hospital, Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib in people with Non-small Cell Lung Cancer, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caicun Zhou, MD,PhD (86-65115006-3050, caicunzhoudr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: tumor assessment every 6-8 weeks after the initiation of pyrotinib, up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535507, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.