ALK PositiveEFLRWRNCT05132218
Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
An observational study of ALK Positive and NSCLC Stage IIIB, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The experimental design is exploratory, single-arm, multi-center, real-world research. Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK Positive, NSCLC Stage IIIB, NSCLC Stage IV
- What is being tested?
- Ensatinib
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2021to 30 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single arm real world study of non-small cell lung cancer; stage IIIB or stage IV ALK positive NSCLC；
Who may be able to join
- stage IIIB or stage IV NSCLC by histology or cytology;
- All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
- Without any ALK-TKI treatment;
- Voluntarily and capable of following the trial and follow-up procedures;
- Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form.
Who cannot join
- 1. Pereceived any ALK-TKI treatment ; 2. Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. The investigator believes that the patient is not suitable for Ensatinib treatment.
- Had a stem cell or organ transplant. 4. Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg).
- 6. Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion.
- 7. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.
Trial locations and contacts
1 site in 1 country.
Xue Yang Yang contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100176
Jie Li, PhD, 010-88196391, xiaotong10241@sina.com
About this study
Official title: Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
The experimental design is exploratory, single-arm, multi-center, real-world research.
Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC
- Efficacy and safety;
- The relationship between molecular mechanism and curative effect;
- Ensatinib resistance mechanism;
Read the detailed description
Enrolled patients:
- stage IIIB or stage IV NSCLC
- Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
- Without any ALK-TKI treatment; Study endpoint
Primary endpoint:
According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;
Secondary endpoint:
According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;
Exploratory endpoint:
The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;
The sample size is determined:
The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:
- Conditions
- ALK Positive, NSCLC Stage IIIB, NSCLC Stage IV
- Being tested
- Ensatinib
- 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.
EnsatinibDrug
Also called BD-EN-IV002
Prospective, exploratory, single-arm, multi-center, real-world research
| Study group | Role | What they receive |
|---|---|---|
| Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer | Ensatinib 225mg QD Until the disease progresses or intolerance Receives: Drug: Ensatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 2021.09.27-2024.12.30
Secondary outcomes (2)
overall survival
Measured: 2021.09.27-2024.12.30
Time-to-TreatmentFailure
Measured: 2021.09.27-2024.12.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start19 Oct 2021
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK PositiveStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Responsible party
- Principal investigator, Jun Zhao, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132218
- Sponsor's protocol ID
- BD-EN-IV002
- Acronym
- EFLRWR
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05132218
- Acronym / sponsor ID
- EFLRWR / BD-EN-IV002
- Conditions
- ALK Positive, NSCLC Stage IIIB, NSCLC Stage IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Betta Pharmaceuticals Co., Ltd.
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 24 Nov 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.
The experimental design is exploratory, single-arm, multi-center, real-world research.
Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC
- Efficacy and safety;
- The relationship between molecular mechanism and curative effect;
- Ensatinib resistance mechanism;
Detailed description
Enrolled patients:
- stage IIIB or stage IV NSCLC
- Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
- Without any ALK-TKI treatment; Study endpoint
Primary endpoint:
According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;
Secondary endpoint:
According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;
Exploratory endpoint:
The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;
The sample size is determined:
The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer | – | Drug: EnsatinibEnsatinib 225mg QD Until the disease progresses or intolerance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single arm real world study of non-small cell lung cancer; stage IIIB or stage IV ALK positive NSCLC；
Key inclusion criteria (5 listed)
- stage IIIB or stage IV NSCLC by histology or cytology;
- All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
- Without any ALK-TKI treatment;
- Voluntarily and capable of following the trial and follow-up procedures;
- Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form.
Key exclusion criteria (4 listed)
- 1. Pereceived any ALK-TKI treatment ; 2. Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. The investigator believes that the patient is not suitable for Ensatinib treatment.
- Had a stem cell or organ transplant. 4. Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg).
- 6. Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion.
- 7. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.
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 |
|---|---|---|
| EnsatinibAlso: BD-EN-IV002Prospective, exploratory, single-arm, multi-center, real-world research | Drug | Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer |
Primary outcome
progression-free survival
Time frame: 2021.09.27-2024.12.30
2 secondary outcomes
overall survival
Time frame: 2021.09.27-2024.12.30
Time-to-TreatmentFailure
Time frame: 2021.09.27-2024.12.30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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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.
Xue Yang Yang contact
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 ALK Positive and NSCLC Stage IIIB, run by Peking University Cancer Hospital & Institute 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 5 inclusion and 4 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 24 Nov 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.
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 Jun Zhao, PhD (13521469335, ohjerry@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 2021.09.27-2024.12.30). 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 24 Nov 2021.