Carcinoma, Non-Small-Cell LungNCT05498064
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
An observational study of Carcinoma, Non-Small-Cell Lung and Anaplastic Lymphoma Kinase I1171N, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N, Ensartinib
- What is being tested?
- Ensartinib
- Type of treatment
- Pill or oral medicine
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2022to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically or cytologically confirmed stage III b or IV NSCLC with ALK -rearrangement
Who may be able to join
- Histologically or cytologically confirmed stage III b or IV NSCLC, according to the International Association for the Study of Lung Cancer staging manual in Thoracic Oncology, 8th edition.
- Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS;
- Patients must have demonstrated progression during or after ALK-TKI treatment;
- Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival>3 months;
- Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc.
- Initially general blood tests including complete blood count, biochemistry, electrolytes, and urine biochemistry were performed as a routine screening in order to identify any abnormalities.
- Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yan Xu, Dr., 8601069155154, maraxu@163.com
Mengzhao Wang
About this study
Official title: A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.
Read the detailed description
Participants will receive Ensartinib at 225 mg orally once a day (QD). Treatments will continue until disease progression, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy). At the time of disease progression, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Collection of venous blood sample from participants included 3 times: before treatment, 8 weeks of treatment, and disease progression. Blood specimens of 8 ml were collected each time for ctDNA NGS testing, and evaluation of Ensartinib population pharmacokinetics with blood sampling after 8 weeks.
- Being tested
- Ensartinib
- Keywords
- Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase, Ensartinib, Real world study
- 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.
EnsartinibDrug
Ensartinib 225 mg administered once daily orally
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Defined as time from first dose of Ensartinib to disease progression or death due to any causes
Measured: 36 months
Secondary outcomes (4)
The objective response rate (ORR)
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Measured: 36 months
Overall survival (OS)
OS, defined as time from first dose of Ensartinib to death due to any cause
Measured: 48 months
12 month/24 month/36 month/48 month-overall survival (OS) rate OS
Defined as the time from randomization to death from any cause. The OS rate was estimated based on the landmark analysis.
Measured: 12 months，24 months，36 months，48 months
Incidence of patients experiencing adverse events (AE)
Adverse events are graded according to CTCAE 5.0
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start13 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Responsible party
- Principal investigator, Wang mengzhao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498064
- Sponsor's protocol ID
- BD-EN-IV007
- Status last verified
- Aug 2022
- First submitted
- 17 May 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- 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 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05498064
- Acronym / sponsor ID
- BD-EN-IV007
- Keywords
- Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase, Ensartinib, Real world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Study start
- 13 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 11 Aug 2022 (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 primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.
Detailed description
Participants will receive Ensartinib at 225 mg orally once a day (QD). Treatments will continue until disease progression, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy). At the time of disease progression, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Collection of venous blood sample from participants included 3 times: before treatment, 8 weeks of treatment, and disease progression. Blood specimens of 8 ml were collected each time for ctDNA NGS testing, and evaluation of Ensartinib population pharmacokinetics with blood sampling after 8 weeks.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically confirmed stage III b or IV NSCLC with ALK -rearrangement
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed stage III b or IV NSCLC, according to the International Association for the Study of Lung Cancer staging manual in Thoracic Oncology, 8th edition.
- Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS;
- Patients must have demonstrated progression during or after ALK-TKI treatment;
- Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival>3 months;
- Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| EnsartinibEnsartinib 225 mg administered once daily orally | Drug | – |
Primary outcome
Progression free survival (PFS)
Time frame: 36 months
Defined as time from first dose of Ensartinib to disease progression or death due to any causes
4 secondary outcomes
The objective response rate (ORR)
Time frame: 36 months
Overall survival (OS)
Time frame: 48 months
12 month/24 month/36 month/48 month-overall survival (OS) rate OS
Time frame: 12 months，24 months，36 months，48 months
Incidence of patients experiencing adverse events (AE)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- 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.
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung and Anaplastic Lymphoma Kinase I1171N, run by Peking Union Medical College Hospital 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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Aug 2022. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 36 months). 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 11 Aug 2022.