Lung CancerPhase 2ACTIVENCT04882345

Almonertinib Treats Advanced NSCLC Patients With EGFR Mutations Who Are Safety Intolerant After Osimertinib Treatment

A Phase 2 study testing Almonertinib in people with Lung Cancer and EGFR Gene Mutation, run by Shanghai Chest Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 to 75 years
Conditions the study is for: Lung Cancer, EGFR Gene Mutation
What is being tested?: Almonertinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: 15 Jul 2021to 15 Jan 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

Over 18 years old (including 18 years old) and under 75 years old (including 75 years old)
Histologically or cytologically diagnosed as locally advanced or metastatic NSCLC.
The CTCAE ≥ grade 3 AE related to osimertinib treatment in previous treatment with osimertinib, or platelet count <75×109 / L (≥CTCAE grade 2), white blood cell count <3×109 / L (≥ CTCAE grade 2), total bilirubin> 1.5×ULN (≥CTCAE grade 2), transaminase (ALT/AST)>3.0×ULN (≥CTCAE grade 2), and the toxic reaction has been alleviated or restored to ≤CTCAE grade 1 patient.
Tumor tissue samples diagnosed as locally advanced or metastatic NSCLC are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations). If the tumor tissue is accessible, it is recommended to send the tumor tissue for examination; if the tumor tissue is not accessible or the patient cannot accept a tissue biopsy, a blood sample is also acceptable.
The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 to 1, and it has not deteriorated in the previous 2 weeks, and the minimum expected survival is 12 weeks.
The patient has at least one tumor lesion that can be accurately measured at baseline, and the longest diameter at baseline is ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm). The selected measurement method is suitable for accurate repeat measurement, which can be computed tomography (CT) or magnetic resonance scan (MRI). If there is only one measurable lesion, it can be accepted as the target lesion, and a baseline assessment of the tumor lesion should be performed at least 14 days after the diagnostic biopsy.

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Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after stopping the study treatment and should not breastfeed. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:
Postmenopausal is defined as amenorrhea for at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped.
For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels are within the laboratory postmenopausal reference value range, also It can be considered post-menopausal.
Have received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral fallopian tube ligation.
Male patients should use barrier contraception (i.e. condoms) from screening to 3 months after stopping the study treatment.
The subjects themselves participated voluntarily and signed an informed consent form in writing.

Who cannot join

Have received any of the following treatments:
Have previously received any EGFR tyrosine kinase inhibitor treatment except osimertinib;
The patient had undergone major surgery within 4 weeks before the first administration;
Accept other test drugs, and within 5 half-lives;
Within 7 days before the first administration of the study drug, CYP3A4 strong inhibitors, inducers, or drugs with a narrow therapeutic window that are CYP3A4 sensitive substrates have been used.
Patients with other malignant tumors who need standard treatment or major surgery within 2 years after the first administration of the study treatment.

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As judged by the investigator, there are any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active bleeding-prone constitution, or active infection. No need to check for chronic diseases.
Refractory nausea, vomiting or chronic gastrointestinal disease, inability to swallow study drugs or having undergone extensive bowel resection may affect the full absorption of Almonertinib.
A history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of interstitial pneumonia requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
Meet any of the following cardiac examination results:
The average corrected QT interval (QTc)> 470 msec obtained from 3 ECG examinations in the resting state, the Fridericia formula is used for QT interval correction (QTcF);
Resting ECG suggests that there are various clinically significant rhythms, conduction or ECG morphological abnormalities (such as complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrioventricular block, and PR between Period> 250 msec);
There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT of immediate family members under 40 Any concomitant drugs in the interval;
Left ventricular ejection fraction (LVEF) ≤50%.
Insufficient bone marrow reserve or organ function, reaching the following laboratory limits:
Absolute neutrophil count <1.5×109 / L;
Platelet count <100×109 / L;
Hemoglobin <90 g/L (<9 g/dL);
Alanine aminotransferase> 2.5 times the upper limit of normal (ULN)
Aspartate aminotransferase> 2.5×ULN
Total bilirubin> 1.5×ULN; or Gilbert syndrome (unconjugated hyperbilirubinemia)
Creatinine>1.5×ULN and creatinine clearance rate<50 mL/min (calculated by Cockcroft-Gault formula); only when creatinine>1.5×ULN, creatinine clearance rate needs to be confirmed.
Women who are breastfeeding or whose blood or urine pregnancy test results are positive within 3 days before the first dose of study treatment.
Active fungal, bacterial and/or viral infections requiring systemic treatment.
Have a history of hypersensitivity to any active or inactive ingredients of Almonertinib or to drugs with similar chemical structure to Almonertinib or the same class of Almonertinib.
Any serious or uncontrolled eye disease may increase the safety risk of the patient as judged by the doctor.
Patients who are judged by the investigator who may not comply well with the procedures and requirements of the study.
The investigator judges that there are any patients with conditions that endanger the safety of the patient or interfere with the evaluation of the study.

Trial locations and contacts

No sites are listed yet.

Shun Lu, doctor contact

13601813062

shun_lu@hotmail.com

About this study

Official title: Evaluate the Safety and Efficacy of Almonertinib in the Treatment of Advanced NSCLC Patients With EGFR-sensitive Mutations Who Are Safety Intolerant After Osimertinib Treatment: a Prospective, Multi-center, Single-arm Clinical Trial

Read the detailed description

This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of Almonertinib treatment in patients with EGFR mutation positive and advanced non-small cell lung cancer (NSCLC) who are intolerant to the safety of osimertinib treatment. Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.

Conditions: Lung Cancer, EGFR Gene Mutation
Being tested: Almonertinib
Medical subject headings: Lung Neoplasms

What participants receive

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

AlmonertinibDrug
Also called HS-10296
Almonertinib is a class 1 new drug,the third-generation small molecule EGFR TKI, which can irreversibly and highly selectively inhibit EGFR sensitive mutations (such as exon 19 deletion and L858R mutation) and T790M resistance mutations.
Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.

Study groups in NCT04882345
Study group	Role	What they receive
Almonertinib group	Experimental	Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day. Receives: Drug: Almonertinib

What is being measured

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

Assess the safety of Almonertinib: Number of AEs/SAEs
Number of adverse events (AEs)/serious adverse events (SAEs)
Measured: Continuously throughout the study until 28 days after Termination of the treatment

Secondary outcomes (6)

Assess the anti-tumor activity: Progression Free Survival (PFS)
To assess the efficacy of Almonertinib in the treatment of advanced NSCLC patients with EGFR-sensitive mutations who are intolerant to safety after osimertinib treatment by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Measured: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Objective response rate (ORR)
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.
Measured: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Disease control rate (DCR)
The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.
Measured: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Duration of response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression assessed up to 24 months.
Measured: the time from date of documented progression or death in the absence of disease progression assessed up to 24 months.
Assess the anti-tumor activity: Overall survival (OS)
Start of study drug to Survival Endpoint through study completion, an average of 4 years.
Measured: an average of 4 years
Assess the anti-tumor activity: Depth of Remission (DepOR）
The depth of remission (change in tumor size) refers to the amount of change in the sum of the length of the longest diameter of the target lesion defined by RECIST 1.1 when no new lesions appear or no non-target lesions have progressed compared with the baseline.
Measured: through study completion, an average of 1 year

Timeline

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

15 Jul 202115 Jan 2024

First posted11 May 2021
Study start15 Jul 2021 (estimated)
Primary completion15 Jan 2024 (estimated)
Study completion15 Jan 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Shanghai Chest 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04882345
Sponsor's protocol ID: YX-L-202109
Acronym: ACTIVE
Status last verified: May 2021
First submitted: 30 Apr 2021
Last updated: 11 May 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Shun Lu, doctor

13601813062

shun_lu@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluate the Safety and Efficacy of Almonertinib in the Treatment of Advanced NSCLC Patients With EGFR-sensitive Mutations Who Are Safety Intolerant After Osimertinib Treatment: a Prospective, Multi-center, Single-arm Clinical Trial
ClinicalTrials.gov ID: NCT04882345
Acronym / sponsor ID: ACTIVE / YX-L-202109
Conditions: Lung Cancer, EGFR Gene Mutation
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Shanghai Chest HospitalUniversity, hospital or other
Collaborators: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study start: 15 Jul 2021 (estimated)
Primary completion: 15 Jan 2024 (estimated)
Study completion: 15 Jan 2024 (estimated)
First posted: 11 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Almonertinib group	Experimental	Drug: AlmonertinibPatients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Over 18 years old (including 18 years old) and under 75 years old (including 75 years old)
Histologically or cytologically diagnosed as locally advanced or metastatic NSCLC.
The CTCAE ≥ grade 3 AE related to osimertinib treatment in previous treatment with osimertinib, or platelet count <75×109 / L (≥CTCAE grade 2), white blood cell count <3×109 / L (≥ CTCAE grade 2), total bilirubin> 1.5×ULN (≥CTCAE grade 2), transaminase (ALT/AST)>3.0×ULN (≥CTCAE grade 2), and the toxic reaction has been alleviated or restored to ≤CTCAE grade 1 patient.
Tumor tissue samples diagnosed as locally advanced or metastatic NSCLC are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations). If the tumor tissue is accessible, it is recommended to send the tumor tissue for examination; if the tumor tissue is not accessible or the patient cannot accept a tissue biopsy, a blood sample is also acceptable.
The Eastern Cooperative Oncology Group (ECOG) physical status score is 0 to 1, and it has not deteriorated in the previous 2 weeks, and the minimum expected survival is 12 weeks.

Key exclusion criteria (28 listed)

Have received any of the following treatments:
Patients with other malignant tumors who need standard treatment or major surgery within 2 years after the first administration of the study treatment.
As judged by the investigator, there are any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active bleeding-prone constitution, or active infection. No need to check for chronic diseases.
Refractory nausea, vomiting or chronic gastrointestinal disease, inability to swallow study drugs or having undergone extensive bowel resection may affect the full absorption of Almonertinib.
A history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of interstitial pneumonia requiring steroid therapy, or any evidence 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
AlmonertinibAlso: HS-10296Almonertinib is a class 1 new drug,the third-generation small molecule EGFR TKI, which can irreversibly and highly selectively inhibit EGFR sensitive mutations (such as exon 19 deletion and L858R mutation) and T790M resistance mutations. Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day.	Drug	Almonertinib group

Primary outcome

Assess the safety of Almonertinib: Number of AEs/SAEs
Time frame: Continuously throughout the study until 28 days after Termination of the treatment
Number of adverse events (AEs)/serious adverse events (SAEs)

6 secondary outcomes

Assess the anti-tumor activity: Progression Free Survival (PFS)
Time frame: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Objective response rate (ORR)
Time frame: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Disease control rate (DCR)
Time frame: From date of baseline until the date of disease progression or discontinuation from study, assessed up to 24 months
Assess the anti-tumor activity: Duration of response (DoR)
Time frame: the time from date of documented progression or death in the absence of disease progression assessed up to 24 months.
Assess the anti-tumor activity: Overall survival (OS)
Time frame: an average of 4 years
Assess the anti-tumor activity: Depth of Remission (DepOR）
Time frame: through study completion, an average of 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Individual participant dataSharing planned: No

Related trials for Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

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.

Shun Lu, doctor contact

13601813062

shun_lu@hotmail.com

Yongsheng Li principal investigator

The Affiliated Cancer Hospital of Chongqing University

Jianying Zhou principal investigator

First Affiliated Hospital of Zhejiang University

Xiuyu Cai principal investigator

Sun Yat-sen University

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Almonertinib in people with Lung Cancer and EGFR Gene Mutation, run by Shanghai Chest Hospital.

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 12 inclusion and 28 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

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 Shun Lu, doctor (13601813062, shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the safety of Almonertinib: Number of AEs/SAEs (time frame: Continuously throughout the study until 28 days after Termination of the treatment). 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 NCT04882345.

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 May 2021.