HER2 Insertion Mutation Positive Advanced NSCLCPhase 2NCT04144569
PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC
A Phase 2 study testing PD-1 Combined With Pyrotinib in people with HER2 Insertion Mutation Positive Advanced NSCLC, run by Yongchang Zhang at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2 Insertion Mutation Positive Advanced NSCLC
- What is being tested?
- PD-1 Combined With Pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2019to 31 Dec 2024
- 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
- Advanced non-small cell lung cancer confirmed by histology or cytology
- HER2 insertion mutation-positive
- Failure with first-line standard chemotherapy
- with measurable lesions.
Who cannot join
- no measurable tumor lesions
- Patients received PD-1 or Pyrotinib before
Trial locations and contacts
1 site in 1 country.
Xiangyu Zhang, PhD contact
China1 site, 1 recruiting
- Recruiting
Hunan Provincal Tumor Hospital
Changsha, Hunan, 410013
Nong Yang, MD, +86 731 89762323, yangnong0217@163.com
Yongchang Zhang, MD, +86 731 89762327, zhangyongchang@csu.edu.cn
About this study
Official title: the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer
The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer
- Being tested
- PD-1 Combined With Pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 Combined With PyrotinibDrug
PD-1 Combined With Pyrotinib
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Combined With Pyrotinib | Experimental | PD-1 combined With pyrotinib used fo first-line chemotherapy failedr HER2 Insertion mutation positive advanced NSCLC Receives: Drug: PD-1 Combined With Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: Approximately 1 years
Secondary outcomes (2)
ORR
To measure the patients's overall response rate
Measured: Approximately 1 years
OS
Overall survival
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start30 Jan 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Insertion Mutation Positive Advanced NSCLCStudies 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongchang Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144569
- Sponsor's protocol ID
- POETHIS
- Status last verified
- Sep 2024
- First submitted
- 28 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04144569
- Acronym / sponsor ID
- POETHIS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yongchang ZhangUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Oct 2019 (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.
The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced 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
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| PD-1 Combined With Pyrotinib | Experimental | Drug: PD-1 Combined With PyrotinibPD-1 combined With pyrotinib used fo first-line chemotherapy failedr HER2 Insertion mutation positive advanced NSCLC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced non-small cell lung cancer confirmed by histology or cytology
- HER2 insertion mutation-positive
- Failure with first-line standard chemotherapy
- with measurable lesions.
Key exclusion criteria (2 listed)
- no measurable tumor lesions
- Patients received PD-1 or Pyrotinib before
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 |
|---|---|---|
| PD-1 Combined With PyrotinibPD-1 Combined With Pyrotinib | Drug | PD-1 Combined With Pyrotinib |
Primary outcome
PFS
Time frame: Approximately 1 years
Progression free survival
2 secondary outcomes
ORR
Time frame: Approximately 1 years
OS
Time frame: Approximately 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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.
Xiangyu Zhang, PhD contact
Yongchang Zhang, MD principal investigator
Hunan Province Tumor Hospital
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 PD-1 Combined With Pyrotinib in people with HER2 Insertion Mutation Positive Advanced NSCLC, run by Yongchang Zhang 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 4 inclusion and 2 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 19 Sep 2024. 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 Yongchang Zhang, MD (+8613873123436 ext. +8613873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Approximately 1 years). 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 19 Sep 2024.