Lung Cancer, Non-small CellPhase 2NCT04706949
Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment
A Phase 2 study testing Pyrotinib combined with pemetrexed plus carboplatin in people with Lung Cancer, Non-small Cell, run by Fudan University at 1 site in China.
Trial summary
A prospective, single center, single arm, phase II clinical trial of Pyrotinib combined with pemetrexed plus carboplatin in the first-line treatment of patients with HER2 mutant or amplified recurrent / metastatic non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Non-small Cell
- What is being tested?
- Pyrotinib combined with pemetrexed plus carboplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2020to 31 Dec 2022
- 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
- Aged≥18 and <75 years.
- Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to UICC 2017.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 3 months.
- Confirmed HER2 mutation and amplification by Central Laboratory. Direct sequencing (RT-PCR or ARMS-PCR) or second generation sequencing (NGS) was used for HER2 mutation, and fluorescence in situ hybridization (FISH) or ngs was used for HER2 amplification;
- At least one RECIST 1.1 defined measurable lesions.
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- Patients who had not received systemic treatment for advanced / metastatic NSCLC in the past but had disease progression more than 12 months after receiving neoadjuvant therapy or the last use of adjuvant therapy could be enrolled.
- Required laboratory values including following parameters:ANC≥1.5×109/L,Platelet count≥90×109/L,Hemoglobin≥90 g/L;Total bilirubin:≤ 1.5×upper limit of normal, ULN, ALT and AST≤ 2.0×ULN; 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.
- Inability to swallow、chronic diarrhea and intestinal obstruction that affect the drug taking and absorption.
- There is unstable third space effusion (such as large amount of pleural effusion and ascites).
- Received radiotherapy, chemotherapy, surgery or other targeted therapy for non-small cell lung adenocarcinoma within 4 weeks before taking the study drug for the first time.
- Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1).
- Patients with active brain metastasis (without medical control), cancerous meningitis, spinal cord compression, or diseases of brain or pia mater found by CT or MRI examination during screening (patients with brain metastasis who had completed treatment or stable symptoms within 28 days before taking the study drug for the first time can be enrolled, but they need to be confirmed as having no symptoms of cerebral hemorrhage by MRI, CT or venography evaluation).
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- Participated in other drug clinical trials within the past 4 weeks before start of therapy.
- Other malignant tumors in the past 5 years, excluding cervical carcinoma in situ, basal cell carcinoma of skin or squamous cell carcinoma of skin.
- At the same time receive any other anti-tumor treatment, such as immune agents and anti angiogenesis inhibitors.
- Those with allergic constitution or known allergic history to the drug components of the scheme.
- Active infection(judged by the researcher).
- 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.
- According to the judgment of the researchers, there are concomitant diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that seriously endanger the safety of patients or affect the completion of the study.
- Known history of neurological or psychiatric disease, including epilepsy or dementia.
- 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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
wang jia lei, DOCTOR, 18017312689, haitunqiao@hotmail.com
About this study
Official title: A Prospective, Single Center, Single Arm, Phase II Clinical Trial of Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment of Patients With HER2 Mutant or Amplified Recurrent / Metastatic Non-small Cell Lung Cancer
A prospective, single center, single arm, phase II clinical trial of Pyrotinib combined with pemetrexed plus carboplatin in the first-line treatment of patients with HER2 mutant or amplified recurrent / metastatic non-small cell lung cancer
- Conditions
- Lung Cancer, Non-small Cell
- Being tested
- Pyrotinib combined with pemetrexed plus carboplatin
- Keywords
- Lung Cancer, Non-small Cell
- 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.
Pyrotinib combined with pemetrexed plus carboplatinDrug
- Pyrotinib: oral administration within 30 minutes after breakfast, 400mg / day, continuous administration for 21 days as a cycle; each continuous pause time and the cumulative pause time of each cycle should not exceed 14 days. It is allowed to suspend the drug for many times due to adverse events.
- Pemetrexed: the recommended dosage is 500mg / m2, once every three weeks. 3) Carboplatin: the dosage was determined according to Calvert formula, in which AUC was 5mg / ml / min.
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib combined with pemetrexed plus carboplatin | Experimental | Not described Receives: Drug: Pyrotinib combined with pemetrexed plus carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start7 Dec 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-small CellStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706949
- Sponsor's protocol ID
- BLTN-HER2-001
- Status last verified
- Jan 2021
- First submitted
- 28 Dec 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Single Arm, Phase II Clinical Trial of Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment of Patients With HER2 Mutant or Amplified Recurrent / Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04706949
- Acronym / sponsor ID
- BLTN-HER2-001
- Conditions
- Lung Cancer, Non-small Cell
- Keywords
- Lung Cancer, Non-small Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Jan 2021 (actual)
- 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.
A prospective, single center, single arm, phase II clinical trial of Pyrotinib combined with pemetrexed plus carboplatin in the first-line treatment of patients with HER2 mutant or amplified recurrent / metastatic non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib combined with pemetrexed plus carboplatin | Experimental | Drug: Pyrotinib combined with pemetrexed plus carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged≥18 and <75 years.
- Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to UICC 2017.
- ECOG performance status of 0 to 1.
- Life expectancy of more than 3 months.
- Confirmed HER2 mutation and amplification by Central Laboratory. Direct sequencing (RT-PCR or ARMS-PCR) or second generation sequencing (NGS) was used for HER2 mutation, and fluorescence in situ hybridization (FISH) or ngs was used for HER2 amplification;
Key exclusion criteria (16 listed)
- Previous therapy with other HER2 inhibitors.
- Inability to swallow、chronic diarrhea and intestinal obstruction that affect the drug taking and absorption.
- There is unstable third space effusion (such as large amount of pleural effusion and ascites).
- Received radiotherapy, chemotherapy, surgery or other targeted therapy for non-small cell lung adenocarcinoma within 4 weeks before taking the study drug for the first time.
- Persistence of clinically relevant therapy related toxicities from previous therapy (greater than Common Terminology Criteria for Adverse Event(CTCAE) 4.0 grade 1).
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 |
|---|---|---|
| Pyrotinib combined with pemetrexed plus carboplatin1. Pyrotinib: oral administration within 30 minutes after breakfast, 400mg / day, continuous administration for 21 days as a cycle; each continuous pause time and the cumulative pause time of each cycle should not exceed 14 days. It is allowed to suspend the drug for many times due to adverse events. 2. Pemetrexed: the recommended dosage is 500mg / m2, once every three weeks. 3) Carboplatin: the dosage was determined according to Calvert formula, in which AUC was 5mg / ml / min. | Drug | Pyrotinib combined with pemetrexed plus carboplatin |
Primary outcome
PFS
Time frame: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)]
progression free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: No
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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.
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 combined with pemetrexed plus carboplatin in people with Lung Cancer, Non-small Cell, run by Fudan 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 9 inclusion and 16 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 13 Jan 2021. 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 wang jia lei, doctor (18017312369, haitunqiao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2021.