Non-small Cell Lung CancerPhase 3NCT04923906
Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mutations
A Phase 3 study testing Aumolertinib in people with Non-small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Aumolertinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 624 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2021to 31 Jan 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 1. Provision of informed consent before any study-specific procedures, sampling and analyses.
- 2. Male or female, age at least 18 years. 3. Histologically confirmed locally advanced or metastatic NSCLC (included patients with stage IIIB, IIIC or IV disease who had relapsed after prior surgery or were newly diagnosed). Patients must be treatment-naïve for locally advanced or metastatic NSCLC. Prior adjuvant and neo-adjuvant therapies are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.
- 4. The tumor harbors 1 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 assessed by central testing using tumor tissue sample or blood sample.
- 5. At least 1 lesion that has not previously been irradiated, and that can be accurately measured at Baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm).
- 6. An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
- 7. Female patients should be using adequate contraceptive measures and should not be breastfeeding at the screening period, during the study, and six months after the last dosing of study. Patient must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential by fulfilling 1 of the following criteria at screening:
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- Postmenopausal defined as age more than 50 years and amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments.
- Women under 50 years old would be considered postmenopausal if they have been amenorrhea 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 laboratory.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not by tubal ligation.
- 8. Male patients should be willing to use barrier contraception (i.e., condoms).
Who cannot join
- 1. Treatment with any of the following:
- Prior treatment with an EGFR TKI.
- Major surgery (excluding placement of vascular access) within 4 weeks of randomization.
- Radiotherapy to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of randomization.
- Spinal cord compression or brain metastases unless asymptomatic, stable for at least 4 weeks, and not requiring steroids for at least 2 weeks prior to start of study treatment.
- 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.
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- 2. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 at the time of starting study treatment.
- 3. History of other malignancies, excluding full treated non-melanoma skin cancer, in-situ cancer, or other solid tumors that hadn't recurrent for > 5 years following the end of treatment.
- 4. Inadequate bone marrow reserve or organ function. 5. 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.
- Left ventricular ejection fraction (LVEF) < 50%. 6. Any evidence of severe or uncontrolled systemic diseases (including uncontrolled hypertension and active bleeding diatheses) or active infection. Screening for chronic conditions is not required.
- 7. Refractory nausea, vomiting, or chronic gastrointestinal diseases, inability to swallow the study drug, or previous significant bowel resection that would preclude adequate absorption of Aumolertinib.
- 8. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.
- 9. Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit.
- 10. History of hypersensitivity to any active or inactive ingredient of study drugs (pemetrexed, cisplatin, carboplatin, Aumolertinib) or to drugs with a similar chemical structure or class to Aumolertinib.
- 11. 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.
- 12. Any severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion, present a specific risk to the patient's safety.
- 13. 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
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Aumolertinib with or Without Chemotherapy As First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing Epidermal Growth Factor Receptor Mutations: a Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study
To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).
Read the detailed description
HS-10296-306 is a randomized, open-label, multicenter, phase III study to assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+). Eligible patients are randomized to receive either Aumolertinib (110 mg orally, once daily) in combination with platinum-based chemotherapy (every 3 weeks for 4~6 cycles) or Aumolertinib (110 mg orally, once daily) in a 1:1 ratio.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Aumolertinib, Placebo Aumolertinib
- Keywords
- Concurrent Chemotherapy, Aumolertinib, EGFR-TKI, EGFRm+, Ex19Del, L858R, HS-10296, Stage IIIB-IV, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AumolertinibDrug
Also called HS-10296
Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4~6 cycles, followed by Aumolertinib 100mg QD with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles.
Dose may be reduced to allow for the management of investigational drug related toxicity.
Placebo AumolertinibDrug
Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Aumolertinib and platinum-based chemotherapy | Experimental | Not described Receives: Drug: Aumolertinib |
| Aumolertinib | Active comparator | Not described Receives: Drug: Placebo Aumolertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression Free Survival) assessed by IRC (Independent Review Committee)
IRC-PFS is defined as the time from randomization until the date of objective disease progression based on IRC assessment or death (by any cause in the absence of progression). The patients will receive long-term follow-up including chest and abdominal CT every 6 weeks until Week 18, then every 12 weeks and onwards.
Measured: From the time of randomization to disease progression or death, approximately 3 years.
Secondary outcomes (8)
ORR (Objective Response Rate) assessed by IRC (Independent Review Committee)
ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression.
Measured: From the time of randomization to the date of first occurrence of complete response (CR) or partial response (PR), approximately 3 years.
DoR (Duration of response)
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.
Measured: From the time of randomization to disease progression or death, approximately 3 years.
DCR (Disease Control Rate)
The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD.
Measured: From the time of randomization to disease progression or death, approximately 3 years.
DepOR (Depth of Response)
DepOR is defined as the sum of the lengths of the longest diameters of the RECIST 1.1 target lesions.
Measured: From the time of randomization to disease progression or death, approximately 3 years.
PFS (Progression Free Survival) Rate at 12, 18, 24, and 36 months
PFS Rate at 12, 18, 24, and 36 months is defined as proportion of progression free survival at 12, 18, 24, and 36 months from the date of randomization.
Measured: The PFS Rate at 12, 18, 24, and 36 months is assessed up to 36 months.
OS (Overall survival)
Overall survival (OS) is defined as the time from randomization to death due to any cause. The survival will be followed up with telephone every 12 weeks after discontinuation of the randomized treatment.
Measured: From the time of randomization to death due to any cause, approximately 6 years.
OS (Overall survival) rate at 3, 5 years
OS rate at 3, 5 years is defined as the proportion of patients alive at 3, 5 years from the date of randomization.
Measured: The OS rate at 3, 5 years is assessed up to 5 years.
Incidence and severity of AEs (Adverse Events)
AEs are graded according to CTCAE v5.0 and recorded in the case report form.
Measured: From the screening period to 28 days after treatment completion, approximately 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start11 Aug 2021
- Primary completion18 Jun 2024
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923906
- Sponsor's protocol ID
- HS-10296-306
- Status last verified
- Nov 2024
- First submitted
- 10 Jun 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Hu J, Chen J, Yu Y, Meng X, Dong X, Hu Y, Ji Y, Liu H, Wang W, Ning F, Zhang Z, Liu C, Zhang Z, Wang Q, Zheng W, Wang H, Qu X, Chen Z, Fan S, Zhang X, Lu S. Aumolertinib with or without chemotherapy in EGFR-mutated advanced non-small-cell lung cancer (AENEAS2): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Jul;27(7):785-794. doi: 10.1016/S1470-2045(26)00090-2. Epub 2026 Jun 15.
PubMed 42296979
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Aumolertinib with or Without Chemotherapy As First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing Epidermal Growth Factor Receptor Mutations: a Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT04923906
- Acronym / sponsor ID
- HS-10296-306
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Concurrent Chemotherapy, Aumolertinib, EGFR-TKI, EGFRm+, Ex19Del, L858R, HS-10296, Stage IIIB-IV, Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 11 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.
To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).
Detailed description
HS-10296-306 is a randomized, open-label, multicenter, phase III study to assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+). Eligible patients are randomized to receive either Aumolertinib (110 mg orally, once daily) in combination with platinum-based chemotherapy (every 3 weeks for 4~6 cycles) or Aumolertinib (110 mg orally, once daily) in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aumolertinib and platinum-based chemotherapy | Experimental | Drug: Aumolertinib |
| Aumolertinib | Active comparator | Drug: Placebo Aumolertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Provision of informed consent before any study-specific procedures, sampling and analyses.
- 2. Male or female, age at least 18 years. 3. Histologically confirmed locally advanced or metastatic NSCLC (included patients with stage IIIB, IIIC or IV disease who had relapsed after prior surgery or were newly diagnosed). Patients must be treatment-naïve for locally advanced or metastatic NSCLC. Prior adjuvant and neo-adjuvant therapies are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.
- 4. The tumor harbors 1 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 assessed by central testing using tumor tissue sample or blood sample.
- 5. At least 1 lesion that has not previously been irradiated, and that can be accurately measured at Baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm).
- 6. An Eastern Cooperative Oncology Group (ECOG) performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Key exclusion criteria (21 listed)
- 1. Treatment with any of the following:
- 2. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 at the time of starting study treatment.
- 3. History of other malignancies, excluding full treated non-melanoma skin cancer, in-situ cancer, or other solid tumors that hadn't recurrent for > 5 years following the end of treatment.
- 4. Inadequate bone marrow reserve or organ function. 5. Any of the following cardiac criteria:
- <!-- -->
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-10296Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4~6 cycles, followed by Aumolertinib 100mg QD with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles. Dose may be reduced to allow for the management of investigational drug related toxicity. | Drug | Aumolertinib and platinum-based chemotherapy |
| Placebo AumolertinibPlacebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity. | Drug | Aumolertinib |
Primary outcome
PFS (Progression Free Survival) assessed by IRC (Independent Review Committee)
Time frame: From the time of randomization to disease progression or death, approximately 3 years.
IRC-PFS is defined as the time from randomization until the date of objective disease progression based on IRC assessment or death (by any cause in the absence of progression). The patients will receive long-term follow-up including chest and abdominal CT every 6 weeks until Week 18, then every 12 weeks and onwards.
8 secondary outcomes
ORR (Objective Response Rate) assessed by IRC (Independent Review Committee)
Time frame: From the time of randomization to the date of first occurrence of complete response (CR) or partial response (PR), approximately 3 years.
DoR (Duration of response)
Time frame: From the time of randomization to disease progression or death, approximately 3 years.
DCR (Disease Control Rate)
Time frame: From the time of randomization to disease progression or death, approximately 3 years.
DepOR (Depth of Response)
Time frame: From the time of randomization to disease progression or death, approximately 3 years.
PFS (Progression Free Survival) Rate at 12, 18, 24, and 36 months
Time frame: The PFS Rate at 12, 18, 24, and 36 months is assessed up to 36 months.
OS (Overall survival)
Time frame: From the time of randomization to death due to any cause, approximately 6 years.
OS (Overall survival) rate at 3, 5 years
Time frame: The OS rate at 3, 5 years is assessed up to 5 years.
Incidence and severity of AEs (Adverse Events)
Time frame: From the screening period to 28 days after treatment completion, approximately 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Derived from this study: PubMed 42296979Li Z, Hu J, Chen J, Yu Y, Meng X, Dong X, Hu Y, Ji Y, Liu H, Wang W, Ning F, Zhang Z, Liu C, Zhang Z, Wang Q, Zheng W, Wang H, Qu X, Chen Z, Fan S, Zhang X, Lu S. Aumolertinib with or without chemotherapy in EGFR-mutated advanced non-small-cell lung cancer (AENEAS2): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Jul;27(7):785-794. doi: 10.1016/S1470-2045(26)00090-2. Epub 2026 Jun 15.
- 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.
Shun Lu, MD principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aumolertinib in people with Non-small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. 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 10 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
PFS (Progression Free Survival) assessed by IRC (Independent Review Committee) (time frame: From the time of randomization to disease progression or death, approximately 3 years.). 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 NCT04923906, which also lists 1 linked publication.
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 25 Nov 2024.