Lung CancerPhase 2AERESANCT06227897
Aumolertinib in EGFR-Mutant Resected Stage IB-IIIA NSCLC (AERESA).
A Phase 2 study testing Aumolertinib in people with Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI showing activity against EGFR-sensitizing mutations and EGFR T790M mutation. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Aumolertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Apr 2029
- 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
- Target population is high risk NSCLC with resection option for potential cure, as assessed by a faculty surgeon at SYSUCC. This may include clinical stage IB (≥4cm), II and IIIA. Subjects with N3 nodal involvement are not included.
- Subjects should have a detected sensitizing EGFR.
- Written informed consent provided.
- Male and female, aged 18-75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Blood and specimens before and after treatment must be provided
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥12 weeks.
- EGFR activating mutation in exon 19 or 21.
- Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
Who cannot join
- Known severe hypersensitivity to aumolertinib or any of the excipients of this product.
- Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Evidence of clinically active interstitial lung disease.
- Eye inflammation not fully controlled or conditions predisposing the subject to this.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
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- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Women who are pregnant or nursing.
- Ingredients mixed with small cell lung cancer patients.
- History of neurologic or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Arm, Open-Lable Study of Adjuvant Aumolertinib for Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations.
Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI showing activity against EGFR-sensitizing mutations and EGFR T790M mutation. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.
Read the detailed description
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI. Aumolertinib showed activity against EGFR-sensitizing mutations and EGFR T790M mutation. In the phase III AENEAS trial, aumolertinib had improved efficacy to gefitinib with similar safety. In the phase II APOLLO trial, aumolertinib is effective and well-tolerated for patients with advanced NSCLC having an EGFR T790M mutation after disease progression on first- and second-generation EGFR TKI therapy. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.
- Conditions
- Lung Cancer
- Being tested
- Aumolertinib
- Keywords
- Lung cancer, EGFR, adjuvant
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AumolertinibDrug
Also called almonertinib, HS-10296
Aumolertinib 110 mg per day orally for 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Aumolertinib | Experimental | Aumolertinib 110 mg once daily (110 mg per day) orally for 36 months. Receives: Drug: Aumolertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Disease Free Survival
3-year DFS was defined as the proportion of patients who were disease free at 3 years.
Measured: 3 years after the last patient is randomized
Secondary outcomes (4)
Disease Free Survival
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
Measured: 3 years
Adverse Events
Adverse Events were monitored according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
Measured: 2 years after the last patient is randomized
Number of participants with perioperative complications
Number of participants with perioperative complications
Measured: 2 years
3-year Overall Survival
3-year OS was defined as the proportion of patients who were alive at 3 years.
Measured: 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.
- First posted29 Jan 2024
- Study start1 Jun 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2029 (estimated)
Why it stopped: Slow accrual
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 Sun Yat-sen UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Yu Wang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227897
- Sponsor's protocol ID
- GASTO10109
- Acronym
- AERESA
- Status last verified
- Dec 2024
- First submitted
- 19 Jan 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Lable Study of Adjuvant Aumolertinib for Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations.
- ClinicalTrials.gov ID
- NCT06227897
- Acronym / sponsor ID
- AERESA / GASTO10109
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, EGFR, adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 29 Jan 2024 (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.
Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI showing activity against EGFR-sensitizing mutations and EGFR T790M mutation. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.
Detailed description
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI. Aumolertinib showed activity against EGFR-sensitizing mutations and EGFR T790M mutation. In the phase III AENEAS trial, aumolertinib had improved efficacy to gefitinib with similar safety. In the phase II APOLLO trial, aumolertinib is effective and well-tolerated for patients with advanced NSCLC having an EGFR T790M mutation after disease progression on first- and second-generation EGFR TKI therapy. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aumolertinib | Experimental | Drug: AumolertinibAumolertinib 110 mg once daily (110 mg per day) orally for 36 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Target population is high risk NSCLC with resection option for potential cure, as assessed by a faculty surgeon at SYSUCC. This may include clinical stage IB (≥4cm), II and IIIA. Subjects with N3 nodal involvement are not included.
- Subjects should have a detected sensitizing EGFR.
- Written informed consent provided.
- Male and female, aged 18-75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Key exclusion criteria (14 listed)
- Known severe hypersensitivity to aumolertinib or any of the excipients of this product.
- Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Evidence of clinically active interstitial lung disease.
- Eye inflammation not fully controlled or conditions predisposing the subject to this.
- Inability to comply with protocol or study procedures.
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 |
|---|---|---|
| AumolertinibAlso: almonertinib, HS-10296Aumolertinib 110 mg per day orally for 3 years. | Drug | Aumolertinib |
Primary outcome
3-year Disease Free Survival
Time frame: 3 years after the last patient is randomized
3-year DFS was defined as the proportion of patients who were disease free at 3 years.
4 secondary outcomes
Disease Free Survival
Time frame: 3 years
Adverse Events
Time frame: 2 years after the last patient is randomized
Number of participants with perioperative complications
Time frame: 2 years
3-year Overall Survival
Time frame: 3 years after the last patient is randomized
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aumolertinib in people with Lung Cancer, run by Sun Yat-sen University 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 13 inclusion and 14 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: withdrawn, as of the sponsor's last update on 10 Dec 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Disease Free Survival (time frame: 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?
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 10 Dec 2024.