The Diagnosis Was ALK Positive NSCLCPhase 2ERSGATRNCT05178511
Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance
A Phase 2 study testing Ensartinib in people with The Diagnosis Was ALK Positive NSCLC and Second Generation ALK-TKI is Resistant, run by Li Zhang, MD at 1 site in China.
Trial summary
After the use of second-generation ALK-TKI drug resistance, about 50% of tissue biopsies showed mutations in the ALK kinase domain, and appropriate ALK-TKI could be selected according to different mutation sites .Phase I/II clinical trials in the US of ensatinib showed ORR of 25% (4/16) in patients previously treated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Diagnosis Was ALK Positive NSCLC, Second Generation ALK-TKI is Resistant, Efficacy of Ensatinib in This Subset of Patients
- What is being tested?
- Ensartinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed histologically or cytologically ;
- Patients confirmed as ALK positive (FISH or Ventana IHC or RT-PCR, NGS) in previous written reports.Disease progression after continuing treatment with prior second-generation ALK-TKI resistance (allowing crizotinib resistance) (as per RECIST 1.1);
- Maximum one chemotherapy is allowed;The interval between the last administration of second-generation ALK-TKI and the trial enrollment should be at least 7 days;
- Gender: both male and female;Age: ≥18 years old;
- physical status score was 0-2;
- survival ≥3 months;
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- certain organ system functions (no blood transfusion or use of constituent blood within 14 days before test)；
- Asymptomatic CNS metastases that do not require treatment with steroids or anticonvulsants;If there is CNS metastasis, radiotherapy can be performed first, and no progress can be made after ≥28 days.Meningeal disease was not included in the group;
- Patients must have measurable lesions according to RECIST1.1 criteria;
- Willing and able to follow the trial and follow-up procedures;
- Able to understand the nature of the experiment and sign written informed consent voluntarily.
Who cannot join
- Patients who had previously only used crizotinib or loratinib；
- Currently receiving other systemic anti-tumor treatments；
- history of malignancy other than lung cancer in the past 3 years (excluding cured basal cell tumor of the skin, early gastrointestinal [GI] tumor resected under endoscope, carcinoma in situ of the cervix)；
- Patients who participated in clinical trials of other investigational drugs within weeks prior to initial ensatinib administration；
- Major surgery or immunotherapy within 4 weeks prior to initial; dosing;Radiation therapy was received within 2 weeks prior to initial dosing；
- In the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results;
- Other conditions considered unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University
Guangzhou, Guangdong, 510060
Fang WenFeng, dooctor
About this study
Official title: a Prospective, Open Phase ii Clinical Study in Patients With alK-positive Non-small Cell Lung Cancer Treated With Ensatinib After Second-generation ALK-TKI Resistance
After the use of second-generation ALK-TKI drug resistance, about 50% of tissue biopsies showed mutations in the ALK kinase domain, and appropriate ALK-TKI could be selected according to different mutation sites .Phase I/II clinical trials in the US of ensatinib showed ORR of 25% (4/16) in patients previously treated with crizotinib and second-generation ALK-TKI (N=16) .In the phase II registered clinical study in China, biomarker analysis also showed that the ORR of ensatinib against drug resistance site G1202R was 33% (2/6).The ORR of I1171 and F1174 were 50% (2/4) and 71% (5/7), respectively, suggesting that ensatinib may still be effective in patients with drug resistance to other second-generation ALK inhibitors . Investigators designed this study to evaluate the clinical efficacy of ensatinib after second-generation ALK-TKI resistance.The study was a single-arm, multi-center Phase II clinical study, using ORR of patients with measurable lesions as the primary endpoint, and using Simon two-stage design to estimate the required sample size.At a 5% level of significance and 85% confidence, a minimum of 40 evaluable subjects were required for both phases.In the first stage, 20 patients were enrolled. If 2 patients had objective response, an additional 20 patients were enrolled in the second stage. If more than 5 patients /40 patients had objective response, the therapeutic drugs were considered effective.Eligible patients will take 225mg of ensaritinib orally once daily, on an empty stomach or with food, until the patient develops disease progression, develops unacceptable toxicity, the investigator or subject decides to drop out, loses follow-up, starts another antitumor therapy, or dies.The primary end points were objective response rate (ORR) to disease progression, occurrence of unacceptable toxicity, investigator or subject decision to drop out, loss of follow-up, initiation of other antitumor therapy, or death.
- Conditions
- The Diagnosis Was ALK Positive NSCLC, Second Generation ALK-TKI is Resistant, Efficacy of Ensatinib in This Subset of Patients
- Being tested
- Ensartinib
- Keywords
- ensartinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsartinibDrug
Also called X-396
Ensaritinib was taken orally once 225mg, on an empty stomach or with food, until the patient developed disease progression, developed unacceptable toxicity, the investigator or subject decided to drop out, lost follow-up, initiated other antitumor therapy, or died
| Study group | Role | What they receive |
|---|---|---|
| hydrochloric acid ensartinib | Experimental | Ensatinib 225mg daily, QD, until progression or intolerance Receives: Drug: Ensartinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 0 up to 8 weeks
Secondary outcomes (1)
Progression free survival
Measured: 0 up to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Jul 2023 (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 The Diagnosis Was ALK Positive 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Zhang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Zhang, MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178511
- Sponsor's protocol ID
- BD-EN-IV001
- Acronym
- ERSGATR
- Status last verified
- Jan 2022
- First submitted
- 2 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective, Open Phase ii Clinical Study in Patients With alK-positive Non-small Cell Lung Cancer Treated With Ensatinib After Second-generation ALK-TKI Resistance
- ClinicalTrials.gov ID
- NCT05178511
- Acronym / sponsor ID
- ERSGATR / BD-EN-IV001
- Conditions
- The Diagnosis Was ALK Positive NSCLC, Second Generation ALK-TKI is Resistant, Efficacy of Ensatinib in This Subset of Patients
- Keywords
- ensartinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Li Zhang, MDUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jan 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.
After the use of second-generation ALK-TKI drug resistance, about 50% of tissue biopsies showed mutations in the ALK kinase domain, and appropriate ALK-TKI could be selected according to different mutation sites .Phase I/II clinical trials in the US of ensatinib showed ORR of 25% (4/16) in patients previously treated with crizotinib and second-generation ALK-TKI (N=16) .In the phase II registered clinical study in China, biomarker analysis also showed that the ORR of ensatinib against drug resistance site G1202R was 33% (2/6).The ORR of I1171 and F1174 were 50% (2/4) and 71% (5/7), respectively, suggesting that ensatinib may still be effective in patients with drug resistance to other second-generation ALK inhibitors . Investigators designed this study to evaluate the clinical efficacy of ensatinib after second-generation ALK-TKI resistance.The study was a single-arm, multi-center Phase II clinical study, using ORR of patients with measurable lesions as the primary endpoint, and using Simon two-stage design to estimate the required sample size.At a 5% level of significance and 85% confidence, a minimum of 40 evaluable subjects were required for both phases.In the first stage, 20 patients were enrolled. If 2 patients had objective response, an additional 20 patients were enrolled in the second stage. If more than 5 patients /40 patients had objective response, the therapeutic drugs were considered effective.Eligible patients will take 225mg of ensaritinib orally once daily, on an empty stomach or with food, until the patient develops disease progression, develops unacceptable toxicity, the investigator or subject decides to drop out, loses follow-up, starts another antitumor therapy, or dies.The primary end points were objective response rate (ORR) to disease progression, occurrence of unacceptable toxicity, investigator or subject decision to drop out, loss of follow-up, initiation of other antitumor therapy, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hydrochloric acid ensartinib | Experimental | Drug: EnsartinibEnsatinib 225mg daily, QD, until progression or intolerance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed histologically or cytologically ;
- Patients confirmed as ALK positive (FISH or Ventana IHC or RT-PCR, NGS) in previous written reports.Disease progression after continuing treatment with prior second-generation ALK-TKI resistance (allowing crizotinib resistance) (as per RECIST 1.1);
- Maximum one chemotherapy is allowed;The interval between the last administration of second-generation ALK-TKI and the trial enrollment should be at least 7 days;
- Gender: both male and female;Age: ≥18 years old;
- physical status score was 0-2;
Key exclusion criteria (7 listed)
- Patients who had previously only used crizotinib or loratinib；
- Currently receiving other systemic anti-tumor treatments；
- history of malignancy other than lung cancer in the past 3 years (excluding cured basal cell tumor of the skin, early gastrointestinal [GI] tumor resected under endoscope, carcinoma in situ of the cervix)；
- Patients who participated in clinical trials of other investigational drugs within weeks prior to initial ensatinib administration；
- Major surgery or immunotherapy within 4 weeks prior to initial; dosing;Radiation therapy was received within 2 weeks prior to initial dosing；
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 |
|---|---|---|
| EnsartinibAlso: X-396Ensaritinib was taken orally once 225mg, on an empty stomach or with food, until the patient developed disease progression, developed unacceptable toxicity, the investigator or subject decided to drop out, lost follow-up, initiated other antitumor therapy, or died | Drug | hydrochloric acid ensartinib |
Primary outcome
Objective response rate
Time frame: 0 up to 8 weeks
1 secondary outcome
Progression free survival
Time frame: 0 up to12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: Yes
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 Ensartinib in people with The Diagnosis Was ALK Positive NSCLC and Second Generation ALK-TKI is Resistant, run by Li Zhang, MD 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 11 inclusion and 7 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 5 Jan 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.
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 Wen Feng Feng, Doctor (15322302066, fangwf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 0 up to 8 weeks). 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 5 Jan 2022.