NSCLCNCT04778800

A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY)

A study testing almonertinib, LM-first line treatment and LM-second line treatment in people with NSCLC and Brain Metastases, run by Henan Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC, Brain Metastases, Leptomeningeal Metastasis
What is being tested?: almonertinib, LM-first line treatment and LM-second line treatment
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 20 Mar 2021to 20 Feb 2024
Phase: Interventional
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

Queue 1
Male or female,age at least 18 years ;
Histologically confirmed patients with NSCLC brain metastases (including patients who have relapsed after previous treatment or newly diagnosed);
There must be at least one measurable brain lesion that has not been locally treated at the time of enrollment;
Patients who have not received other systemic treatment after the diagnosis of NSCLC brain metastasis, or patients who have received neoadjuvant therapy, adjuvant therapy, concurrent radiotherapy and chemotherapy, and local radiotherapy for more than 6 months;
Tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS;

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The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2 and has not deteriorated in the previous 2 weeks, with a minimum expected survival of 12 weeks;
The patient is not required to have measurable systemic lesions; if there is, the lesions are required to be in at least one dimension (the largest diameter recorded by non-nodular lesions and the short axis of nodular lesions) ≥10mm by conventional techniques (CT, MRI) Can be accurately measured under the circumstances;
The subject himself voluntarily participated and signed an informed consent form.
Queue 2
Male or female,age at least 18 years ;
Histologically confirmed NSCLC patients (including patients who have relapsed after previous treatment or newly diagnosed);
Tumor cells found in cerebrospinal fluid or MRI showed clear meningeal enhancement and patients with dizziness/headache were included as selection criteria;
Patients who have not received other systemic treatment after being diagnosed with stage IV NSCLC, or patients who have received neoadjuvant therapy, adjuvant therapy, and concurrent radiotherapy and chemotherapy for more than 6 months;
The tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS;
The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2 and has not deteriorated in the previous 2 weeks, with a minimum expected survival of 12 weeks;
The patient is not required to have measurable systemic lesions; if there is, the lesions are required to be in at least one dimension (the largest diameter recorded by non-nodular lesions and the short axis of nodular lesions) ≥10mm by conventional techniques (CT, MRI) Can be accurately measured under the circumstances; The subjects themselves participated voluntarily and signed a written informed consent form.
Queue 3
Male or female,age at least 18 years ;
Histologically confirmed patients with stage IV NSCLC (including relapsed or newly diagnosed stage IV patients after previous treatment);
Patients with brain progression or brain lesions that have not resolved after the first/second generation EGFR-TKI treatment;
The patient must have at least one measurable brain lesion that has not been locally treated at the time of enrollment;
The tumor tissue samples or blood are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R) by ARMS;
The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-2 and has not deteriorated in the previous 2 weeks, with a minimum expected survival of 12 weeks;
The patient is not required to have measurable systemic lesions; if there is, the lesions are required to be in at least one dimension (the largest diameter recorded by non-nodular lesions and the short axis of nodular lesions) ≥10mm by conventional techniques (CT, MRI) Can be accurately measured under the circumstances;
The subject himself voluntarily participated and signed an informed consent form.

Who cannot join

the researchers believe that the risks faced by patients after entering the group are greater than those who benefit from them.
patients involved in any other clinical study.
patients with other malignant tumors.
A history of allergic reactions caused by compounds similar to almonertinib or its chemical composition.
pregnant or lactating women.
researchers should not participate in the study if they believe that patients cannot comply with the research procedures and requirements.

Trial locations and contacts

1 site in 1 country.

Huijuan Wang, MD contact

18638561588

18638561588@163.com

China1 site, 1 recruiting

Henan Cancer Hospital
Zhengzhou, Henan, 450003
Wang Huijuan, MD, 18638561588, 18638561588@163.com
Recruiting

Other trials in China

About this study

Official title: A Dose Exploration Study of Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Newly Diagnosed or Recurrent Brain/Leptomeningeal Metastasis (ARTISTRY)

Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study aims to explore the efficacy and safety of different doses of almonertinib in the first-line and second-line treatment of brain metastases/meningeal metastases in NSCLC patients.

Conditions: NSCLC, Brain Metastases, Leptomeningeal Metastasis
Being tested: almonertinib, LM-first line treatment, LM-second line treatment
Medical subject headings: Brain Neoplasms, Meningeal Carcinomatosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

almonertinibDrug
Patients was given a standard dose of 110mg/day of almonertinib, orally, and the first efficacy evaluation was carried out 4 weeks later. If the patient's lungs and/or other parts of the disease (PD) progress, then leave the group to receive other treatment; if the patient's lungs If the brain and other parts are stable or relieved and the brain has not progressed, continue the original dose treatment, and evaluate the effect every 8 weeks. Until the patient's lungs and/or other parts progress (PD), then leave the group to receive other treatment; if If the patient's lungs and other parts are stable or relieved and the brain is progressing, the dose of almonertinib can be increased to 165mg/day, orally ± radiotherapy (the investigator's decision), and then the efficacy will be evaluated every 8 weeks until the patient's lungs and/ Or there is progress (PD) in other parts, then the group will receive other treatment.
LM-first line treatmentDrug
Patients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses.
LM-second line treatmentDrug
Patients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses.

Study groups in NCT04778800
Study group	Role	What they receive
almonertinib 110mg PO once daily	Experimental	Not described Receives: Drug: almonertinib
almonertinib 160mg PO once daily	Experimental	Not described Receives: Drug: LM-first line treatment
almonertinib 220mg PO once daily	Experimental	Not described Receives: Drug: LM-second line treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

iPFS
Intracranial progression-free survival (iPFS)
Measured: Up to approximately 3 years after the last patient is randomized

Secondary outcomes (3)

DCR
Disease control rate (DCR)
Measured: Up to approximately 3 years after the last patient is randomized
PFS
progression-free period (PFS)
Measured: Up to approximately 3 years after the last patient is randomized
OS
overall survival (OS)
Measured: Up to approximately 3 years after the last patient is randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 202120 Feb 2024

First posted3 Mar 2021
Study start20 Mar 2021
Primary completion20 Feb 2023 (estimated)
Study completion20 Feb 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLCStudies of the same condition, open and under way.
More trials run by Henan Cancer 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04778800
Sponsor's protocol ID: HL-HS-006
Status last verified: Aug 2021
First submitted: 27 Jan 2021
Last updated: 31 Aug 2021
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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Exploration Study of Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Newly Diagnosed or Recurrent Brain/Leptomeningeal Metastasis (ARTISTRY)
ClinicalTrials.gov ID: NCT04778800
Acronym / sponsor ID: HL-HS-006
Conditions: NSCLC, Brain Metastases, Leptomeningeal Metastasis
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Henan Cancer HospitalOther government
Study start: 20 Mar 2021 (actual)
Primary completion: 20 Feb 2023 (estimated)
Study completion: 20 Feb 2024 (estimated)
First posted: 3 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
almonertinib 110mg PO once daily	Experimental	Drug: almonertinib
almonertinib 160mg PO once daily	Experimental	Drug: LM-first line treatment
almonertinib 220mg PO once daily	Experimental	Drug: LM-second line treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

Queue 1
Male or female,age at least 18 years ;
Histologically confirmed patients with NSCLC brain metastases (including patients who have relapsed after previous treatment or newly diagnosed);
There must be at least one measurable brain lesion that has not been locally treated at the time of enrollment;
Patients who have not received other systemic treatment after the diagnosis of NSCLC brain metastasis, or patients who have received neoadjuvant therapy, adjuvant therapy, concurrent radiotherapy and chemotherapy, and local radiotherapy for more than 6 months;

Key exclusion criteria (6 listed)

the researchers believe that the risks faced by patients after entering the group are greater than those who benefit from them.
patients involved in any other clinical study.
patients with other malignant tumors.
A history of allergic reactions caused by compounds similar to almonertinib or its chemical composition.
pregnant or lactating women.

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
almonertinibPatients was given a standard dose of 110mg/day of almonertinib, orally, and the first efficacy evaluation was carried out 4 weeks later. If the patient's lungs and/or other parts of the disease (PD) progress, then leave the group to receive other treatment; if the patient's lungs If the brain and other parts are stable or relieved and the brain has not progressed, continue the original dose treatment, and evaluate the effect every 8 weeks. Until the patient's lungs and/or other parts progress (PD), then leave the group to receive other treatment; if If the patient's lungs and other parts are stable or relieved and the brain is progressing, the dose of almonertinib can be increased to 165mg/day, orally ± radiotherapy (the investigator's decision), and then the efficacy will be evaluated every 8 weeks until the patient's lungs and/ Or there is progress (PD) in other parts, then the group will receive other treatment.	Drug	almonertinib 110mg PO once daily
LM-first line treatmentPatients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses.	Drug	almonertinib 160mg PO once daily
LM-second line treatmentPatients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses.	Drug	almonertinib 220mg PO once daily

Primary outcome

iPFS
Time frame: Up to approximately 3 years after the last patient is randomized
Intracranial progression-free survival (iPFS)

3 secondary outcomes

DCR
Time frame: Up to approximately 3 years after the last patient is randomized
PFS
Time frame: Up to approximately 3 years after the last patient is randomized
OS
Time frame: Up to approximately 3 years after the last patient is randomized

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.

Huijuan Wang, MD contact

18638561588

18638561588@163.com

Huijuan Wang, MD principal investigator

Henan Cancer Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing almonertinib, LM-first line treatment and LM-second line treatment in people with NSCLC and Brain Metastases, run by Henan Cancer 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 26 inclusion and 6 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 31 Aug 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 Huijuan Wang, MD (18638561588, 18638561588@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

iPFS (time frame: Up to approximately 3 years after the last patient is randomized). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04778800.

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 31 Aug 2021.