Lung CancerPhase 2APPOINTNCT04922138
Aumolertinib Adjuvant Therapy of Resectable Stage I EGFRm+ NSCLC With High-grade Patterns
A Phase 2 study testing Aumolertinib in people with Lung Cancer, run by Baohui Han at 2 sites in China.
Trial summary
Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 104 participants
- Where
- 2 sitesChina
- Study dates
- 14 Jan 2022to 15 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient who meets all of the following inclusion criteria will qualify for entry into the study:
- Male or female, aged at least 18 years.
- Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology.
- Brain examination must be done prior to surgery as it is considered standard of care.
- Patients are pathologically confirmed to be stage I after operation, containing solid, micropapillary, and/or complex gland components ≥10%.
- Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.
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- Providing paraffin embedded section(10-15sheets),wax blocks or fresh frozen tissues.
- Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
- World Health Organization Performance Status of 0 to 1.
- 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 was negative.
- Male patients should be willing to use barrier contraception from screening to stopping study treatment for 3 months.(i.e., condoms).
- For inclusion in study, patient must provide a written informed consent.
- ≤10 weeks between surgery and treatment period
Who cannot join
- Any patient who meets any of the following exclusion criteria will not qualify for entry into the study:
- Treatment with any of the following:
- Pre-operative or post-operative or planned radiation therapy for the current lung cancer
- Pre-operative (neo-adjuvant) platinum based or other chemotherapy
- Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
- Any other anti-tumor treatment for lung cancer(Including proprietary Chinese patent medicine with anti-tumor effects and anti-tumor immunotherapy, etc.)
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- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
- Treatment with an investigational drug within five half-lives of the compound or any of its related material.
- Medications that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug..
- Patients who have had only segmentectomies or wedge resections
- History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of Aumolertinib.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 ms).
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- Inadequate bone marrow reserve or organ function.
- History of hypersensitivity to any active or inactive ingredient of Aumolertinib, or to drugs with a similar chemical structure or class to Aumolertinib.
- Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion, present a specific risk to the patient's safety.
- Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000
Baohui Han, M.D
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Chang Chen, M.D
About this study
Official title: Efficacy and Safety of Aumolertinib as Adjuvant Therapy in Resectable Stage I NSCLC With High-grade Patterns and EGFR-sensitizing Mutations (APPOINT)
Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib.
Read the detailed description
This is a multi-center, two-arm clinical study. In patients with stage I non-squamous non-small cell lung cancer (NSCLC) with EGFR 19del/21L858R with solid, micropapillary, and/or complex gland components ≥10% who have not received any systemic treatment, to evaluate the efficacy and safety of postoperative adjuvant Aumolertinib in NSCLC patients .
- Conditions
- Lung Cancer
- Being tested
- Aumolertinib
- 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 HS-10296
All subjects who meet the enrollment conditions will be included in the Aumolertinib monotherapy group: Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day until recurrence or completion of treatment or reaching the standard of discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day . Receives: Drug: Aumolertinib |
| Arm B | No intervention | Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Disease free survival (DFS) rate
Defined as the proportion of patients alive and disease free at 2 years,estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis
Measured: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (3)
3-, 4-, and 5-year DFS rate
Defined as the proportion of patients alive and disease free at 3, 4 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis.
Measured: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival (OS)
Defined as the time from the date of treatment start until date of death due to any cause
Measured: Start of study drug to Survival Endpoint through study completion, an average of 5 years, assessed up to 60 months
Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey
Defined as a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: From date of treatment start until treatment completion or discontinuation, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start14 Jan 2022
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Oct 2025 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baohui Han
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Baohui Han, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922138
- Sponsor's protocol ID
- HSM-10296-A017
- Acronym
- APPOINT
- Status last verified
- Apr 2023
- First submitted
- 4 Jun 2021
- Last updated
- 21 Apr 2023
- Results posted
- 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aumolertinib as Adjuvant Therapy in Resectable Stage I NSCLC With High-grade Patterns and EGFR-sensitizing Mutations (APPOINT)
- ClinicalTrials.gov ID
- NCT04922138
- Acronym / sponsor ID
- APPOINT / HSM-10296-A017
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Baohui HanUniversity, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 10 Jun 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.
Efficacy and safety of postoperative adjuvant treatment of NSCLC patients with Aumolertinib.
Detailed description
This is a multi-center, two-arm clinical study. In patients with stage I non-squamous non-small cell lung cancer (NSCLC) with EGFR 19del/21L858R with solid, micropapillary, and/or complex gland components ≥10% who have not received any systemic treatment, to evaluate the efficacy and safety of postoperative adjuvant Aumolertinib in NSCLC patients .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AumolertinibOrally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day . |
| Arm B | No intervention | –Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Any patient who meets all of the following inclusion criteria will qualify for entry into the study:
- Male or female, aged at least 18 years.
- Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology.
- Brain examination must be done prior to surgery as it is considered standard of care.
- Patients are pathologically confirmed to be stage I after operation, containing solid, micropapillary, and/or complex gland components ≥10%.
Key exclusion criteria (24 listed)
- Any patient who meets any of the following exclusion criteria will not qualify for entry into the study:
- Treatment with any of the following:
- Patients who have had only segmentectomies or wedge resections
- History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
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: HS-10296All subjects who meet the enrollment conditions will be included in the Aumolertinib monotherapy group: Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day until recurrence or completion of treatment or reaching the standard of discontinuation. | Drug | Arm A |
Primary outcome
2-year Disease free survival (DFS) rate
Time frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Defined as the proportion of patients alive and disease free at 2 years,estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis
3 secondary outcomes
3-, 4-, and 5-year DFS rate
Time frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival (OS)
Time frame: Start of study drug to Survival Endpoint through study completion, an average of 5 years, assessed up to 60 months
Patient health-related quality of life and symptoms (HRQoL) by SF-36v2 Health Survey
Time frame: From date of treatment start until treatment completion or discontinuation, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- 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.
2 sites 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 Baohui Han at 2 sites 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 24 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Baohui Han, doctor (18930858216, 18930858216@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Disease free survival (DFS) rate (time frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 21 Apr 2023.