Non Small Cell LungPhase 2NCT02834936
A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
A Phase 2 study testing pyrotinib in people with Non Small Cell Lung, run by Jiangsu HengRui Medicine Co., Ltd. at 11 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung
- What is being tested?
- pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesChina
- Study dates
- 20 Oct 2016to 20 Jun 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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。
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- More than one prior Platinum based chemotherapy for advanced and/or metastatic, or recurrent NSCLC in neoadjuvant or adjuvant chemotherapy.
- Required laboratory values including following parameters:
- ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤2 x ULN or ALT and AST: ≤5x ULN for patients with liver metastasis; BUN and Cr: ≤1.5 x ULN； creatine clearance rate: ≥ 50 mL/min; LVEF: ≥ 50%; QTcF: < 470 ms for female and < 450 ms for male.
- Signed informed consent
Who cannot join
- 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)
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- Treatment with surgery, chemotherapy, radiotherapy or other target therapy within the past 4 weeks before start of therapy
- Uncontrolled hypertensin,diabetes.
- unstable angina, history of myocardial infarction in the past 6 months, congestive heart failure>NYHA II, serious cardiac arrhythmia
- Active infection
- Variety of factors that affect the oral medication (such as unable to swallow, chronic diarrhea, bowel obstruction and other gastrointestinal disorders or abnormalities
- 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.
- Treatment in another clinical trial within the past 4 weeks before start of therapy
- Any of the other conditions of which researchers believe that the patient is not fit to take part in the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
HR-BLTN-II-NSCLC Investigational Site
Beijing
HR-BLTN-II-NSCLC Investigational Site
Changsha
HR-BLTN-II-NSCLC Investigational Site
Guangzhou
HR-BLTN-II-NSCLC Investigational Site
Hangzhou
HR-BLTN-II-NSCLC Investigational Site
Harbin
HR-BLTN-II-NSCLC Investigational Site
Nanjing
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
HR-BLTN-II-NSCLC Investigational Site
Shanghai
HR-BLTN-II-NSCLC Investigational Site
Suzhou
HR-BLTN-II-NSCLC Investigational Site
Wuhan
HR-BLTN-II-NSCLC Investigational Site
Zhengzhou
About this study
Official title: A Phase 2 Clinica Study: Efficacy and Safety of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
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.
- Conditions
- Non Small Cell Lung
- Being tested
- pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinibDrug
Also called BLTN
| Study group | Role | What they receive |
|---|---|---|
| pyrotinib treatment | Experimental | Not described Receives: Drug: pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: tumor assessment every 6-9 weeks after the initiation of pyrotinib, up to 24 months
Secondary outcomes (2)
Progression Free Survival (PFS)
Measured: up to 24 months
Incidence and Intensity of Adverse Events
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
Measured: From signing informed consent document until 28 days after the last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start20 Oct 2016
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
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 LungStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834936
- Sponsor's protocol ID
- HR-BLTN-Ⅱ-NSCLC
- Status last verified
- Aug 2025
- First submitted
- 13 Jul 2016
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The plan havn't been decided
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 37296463Zhou C, Li X, Wang Q, Gao G, Zhang Y, Chen J, Shu Y, Hu Y, Fan Y, Fang J, Chen G, Zhao J, He J, Wu F, Zou J, Zhu X, Lin X. Pyrotinib in HER2-Mutant Advanced Lung Adenocarcinoma After Platinum-Based Chemotherapy: A Multicenter, Open-Label, Single-Arm, Phase II Study. J Clin Oncol. 2020 Aug 20;38(24):2753-2761. doi: 10.1200/JCO.20.00297. Epub 2020 Jul 2.
PubMed 32614698
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinica Study: Efficacy and Safety of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
- ClinicalTrials.gov ID
- NCT02834936
- Acronym / sponsor ID
- HR-BLTN-Ⅱ-NSCLC
- Conditions
- Non Small Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 15 Jul 2016 (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.
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.
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 | Experimental | Drug: pyrotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| pyrotinibAlso: BLTN | Drug | pyrotinib treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: tumor assessment every 6-9 weeks after the initiation of pyrotinib, up to 24 months
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: up to 24 months
Incidence and Intensity of Adverse Events
Time frame: From signing informed consent document until 28 days after the last drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- 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 32614698Zhou C, Li X, Wang Q, Gao G, Zhang Y, Chen J, Shu Y, Hu Y, Fan Y, Fang J, Chen G, Zhao J, He J, Wu F, Zou J, Zhu X, Lin X. Pyrotinib in HER2-Mutant Advanced Lung Adenocarcinoma After Platinum-Based Chemotherapy: A Multicenter, Open-Label, Single-Arm, Phase II Study. J Clin Oncol. 2020 Aug 20;38(24):2753-2761. doi: 10.1200/JCO.20.00297. Epub 2020 Jul 2.
- Individual participant dataSharing planned: Undecided. The plan havn't been decided
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites 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, run by Jiangsu HengRui Medicine Co., Ltd. at 11 sites 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: tumor assessment every 6-9 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 NCT02834936, 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 2025.