AzTrials
AzTrials

Lung CancerPhase 2NCT05946460

Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity.

A Phase 2 study testing Aumolertinib in people with Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is a prospective, single-center, single-arm, phase II study evaluating the efficacy and safety of neoadjuvant aumolertinib in previously untreated patients with AI-diagnosed EGFR-mutant and resectable pulmonary ground-glass opacity. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
15 Aug 2023to 10 Jul 2025
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

  • Age between 18 years old (including 18) and 75 years old (including 75).
  • No prior history of receiving anti-tumor treatment.
  • Presence of at least one resectable malignant EGFR-mutant pulmonary ground-glass nodule diagnosed by AI (CTR ≤ 0.5, EGFR mutation prediction value ≥ 0.82), with a nodule diameter between 0.8-3cm (including both 0.8cm and 3cm).
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
  • Adequate function of important organs, as follows:
  • Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 9 g/dl.
Show all 14Show fewer
  • Liver: Bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN.
  • Kidney: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 ml/min.
  • Female of childbearing potential must use appropriate contraceptive measures during the study and should not be breastfeeding for at least 3 months after discontinuation of study treatment. Before initiation of treatment, a negative pregnancy test is required, or one of the following criteria should be met to demonstrate no risk of pregnancy:
  • Postmenopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
  • Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the institution.
  • Previously undergone irreversible surgical sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (except for bilateral tubal ligation).
  • Male patients should use barrier contraception (i.e., condoms) from enrollment until 3 months after discontinuation of study treatment.
  • Voluntary participation of the subject and signed informed consent.

Who cannot join

  • Subjects meeting any of the following criteria will be excluded from the study:
  • Diagnosis or treatment of any other malignant tumor within the past 5 years (excluding patients with previously resected basal cell carcinoma of the skin or other in situ cancers).
  • Use of systemic anti-tumor treatment, including chemotherapy, radiotherapy, or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors), before the study enrollment.
  • Prediction of benign nodules or EGFR wild-type after AI tool assessment of the target lesion.
  • Patient's organ system conditions:
  • History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically active interstitial lung disease.
Show all 23Show fewer
  • Evidence of interstitial lung disease detected on baseline CT scan.
  • Evidence of severe or uncontrolled systemic diseases (e.g., unstable or decompensated respiratory, cardiac, hepatic, or renal diseases) as evaluated by the investigator.
  • Any unstable systemic disease (including active infection, Grade III hypertension, unstable angina, congestive heart failure, hepatic or renal disease, or metabolic disease).
  • Inability to take oral medications, requirement for parenteral nutrition, previous surgery affecting absorption, or active gastrointestinal ulceration.
  • Any significant ocular abnormalities, particularly severe dry eye syndrome, severe dry keratoconjunctivitis, severe exposure keratitis, or other conditions that may increase epithelial damage.
  • History of known neurologic or psychiatric disorders, including epilepsy or dementia.
  • Insufficient bone marrow reserve or organ function, as indicated by the following laboratory values:
  • Absolute neutrophil count (ANC) < 1.5 × 10^9/L.
  • Platelet count < 100 × 10^9/L.
  • Hemoglobin < 90 g/L (< 9 g/dL).
  • Alanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) > 2.5 times ULN.
  • Total bilirubin > 1.5 times ULN.
  • Serum creatinine > 1.5 times ULN and creatinine clearance < 60 mL/min (calculated using the Cockcroft-Gault formula); confirmation of creatinine clearance is only required if creatinine is > 1.5 times ULN.
  • Women who are either pregnant or breast-feeding.
  • History of hypersensitivity reactions to any active or inactive components of Aumolertinib or drugs with chemical structures similar to Aumolertinib or in the same class.
  • Patients who may have poor compliance with the study procedures and requirements in the investigator's judgment.

Trial locations and contacts

1 site in 1 country.

Wenhua Liang, M.D contact

+86-13710249454

liangwh1987@163.com

Jianxing He, M.D contact

+86-20-83337792

drjianxing.he@gmail.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Jianxing He, M.D, +86-20-83337792, drjianxing.he@gmail.com

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity: A Single-arm, Phase II Trial

This is a prospective, single-center, single-arm, phase II study evaluating the efficacy and safety of neoadjuvant aumolertinib in previously untreated patients with AI-diagnosed EGFR-mutant and resectable pulmonary ground-glass opacity.

After informed consent signed, enrolled patients will undergo a treatment period and a follow-up period. During the treatment period, patients will receive aumolertinib treatment (110mg, p.o., QD) for 8 weeks. The surgery can be performed after a 1 to 2-week discontinuation period; if the patient does not consent to undergo surgery, follow-up can be conducted instead. If patients experience disease progression during the treatment period, they will be withdrawn from the study. During the follow-up period, the investigator will provide appropriate treatment recommendations based on the patient's condition and pathological results after surgical resection of the target lesion. Postoperative patients (or patients who completed the medication treatment and were followed up) will be monitored every six months for a duration of one year.

Conditions
Lung Cancer
Being tested
Aumolertinib
Keywords
Aumolertinib, Neoadjuvant Treatment, AI-diagnosed, EGFR-mutant, Ground-glass Opacity
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

    Aumolertinib treatment (110mg, p.o., QD) for 8 weeks

Study groups in NCT05946460
Study groupRoleWhat they receive
Neoadjuvant AumolertinibExperimentalSingle Arm
Receives: Drug: Aumolertinib

What is being measured

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

  1. ORR (Objective Response Rate)

    ORR (Objective Response Rate) is defined as the proportion of participants who confirmed at least one CR (Complete Response) or PR (Partial response) before disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST)1.1 as assessed by the investigator.

    Measured: 3 months.

Secondary outcomes (4)

  1. pCR (Pathological Complete Response)

    pCR (Pathological Complete Response) is defined as the proportion of patients in whom no tumor cells are found in all pathological samples after surgical resection following neoadjuvant treatment.

    Measured: 3 months.

  2. MPR (Major Pathological Response)

    MPR (Major Pathological Response) is defined as the presence of residual tumor of less than 10% on pathological assessment after neoadjuvant treatment-induced tumor regression.

    Measured: 3 months.

  3. PFS (Progression-Free Survival)

    PFS (Progression-Free Survival) is defined as the time from the first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression.

    Measured: 1 year.

  4. OS (Overall Survival)

    OS (Overall Survival) is defined as the time from the initial administration of treatment to the date of death due to any cause. Patients who have not died at the time of statistical analysis will have their survival time censored at the last known date of their survival.

    Measured: 1 year.

Timeline

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

  1. First posted14 Jul 2023
  2. Study start15 Aug 2023
  3. Primary completion10 Jul 2025 (estimated)
  4. Study completion10 Jul 2025 (estimated)

Resources

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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05946460
Sponsor's protocol ID
CATO-2301
Status last verified
Feb 2024
First submitted
7 Jul 2023
Last updated
6 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aumolertinib in people with Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical 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 14 inclusion and 23 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 6 Feb 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wenhua Liang, M.D (+86-13710249454, liangwh1987@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (Objective Response Rate) (time frame: 3 months.). 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 NCT05946460.

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 6 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in