Non Small Cell Lung CancerPhase 3NCT03849768
A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients
A Phase 3 study testing HS-10296 and Gefitinib in people with Non Small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, controlled, double-blind, multicenter, phase III clinical study. 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?
- HS-10296 and Gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 30 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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:
- Provision of informed consent prior to any study specific procedures, sampling and analyses.
- Male or female, age at least 18 years.
- Pathologically confirmed locally advanced or metastatic NSCLC (e.g. this may occur systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with stage IIIB/IV disease). Patients must be treatment-naïve for locally advanced or metastatic NSCLC. Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) provided all other entry criteria are satisfied.
- The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either or in combination with other EGFR mutations assessed by central testing using tumour tissue sample or blood sample.
- A WHO performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Show all 14Show fewer
- At least 1 lesion that has not previously been irradiated, that has not been chosen for biopsy during the study screening period, and that can be accurately measured at Baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), whichever is suitable for accurately repeated measurements. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and baseline tumour assessment scans are done at least 14days afar the screening biopsy is performed.
- Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and 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:
- Postmenopausal defined as age more than 50 years and amenorrheic 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 amenorrheic 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.
- Male patients should be willing to use barrier contraception (i.e., condoms).
- For inclusion in study, patient must provide a written informed consent.
- -
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:
- Prior treatment with systemic anti-cancer therapy for locally advancer or metastatic NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.
- Prior treatment with an EGFR TKI.
- Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
- Radiotherapy with a limited field of radiation for palliation within 4 week of the first dose of study drug, with the exception of patients receiving radiation to > 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
Show all 32Show fewer
- 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.
- Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug.
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study treatment.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial OR which would jeopardize compliance with the protocol such as active infection. Screening for chronic conditions is not required.
- Refractory nausea, vomiting, or chronic gastrointestinal diseases, inability to swallow the study drug, or previous significant bowel resection that would preclude adequate absorption of HS 10296.
- 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) ≤ 40%.
- 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.
- Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values:
- Absolute neutrophil count (ANC) <1.5×109 / L
- Platelet count <100×109 / L
- Hemoglobin <90 g/L（<9 g/dL）
- Alanine aminotransferase > 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or > 5 × ULN in the presence of liver metastases.
- Aspartate aminotransferase (AST) > 2.5 × ULN if no demonstrable liver metastases or > 5 × ULN in the presence of liver metastases.
- Total bilirubin (TBL) > 1.5 × ULN if no liver metastases or > 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.
- Creatinine > 1.5 × ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by the Cockcroft-Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 × ULN.
- Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit.
- History of hypersensitivity to any active or inactive ingredient of HS 10296 or to drugs with a similar chemical structure or class to HS 10296.
- 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 severe and uncontrolled ocular disease that may, in the ophthalmologist's opinion, present a specific risk to the patient's safety.
- 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: A Phase III Randomized, Controlled, Double-Blind, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of HS-10296 Versus Gefitinib as First-Line Therapy for Locally Advanced or Metastatic NSCLC With EGFR Sensitizing Mutations
This is a randomized, controlled, double-blind, multicenter, phase III clinical study.
Read the detailed description
This is a randomized, controlled, double-blind, multicenter, phase III clinical trial, evaluating the efficacy and safety of HS-10296 compared to gefitinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor sensitizing mutations (EGFRm+) who have not received systemic therapy. Patients are randomly assigned to an HS-10296 treatment group or a gefitinib treatment group at a ratio of 1:1 and receive a once-daily oral dose of HS-10296 or gefitinib, in order to compare the efficacy and safety of the two different treatment regimens.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HS-10296, Gefitinib
- 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.
HS-10296Drug
Also called Investigational Product
Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
GefitinibDrug
Also called Comparator Product
Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| HS-10296 | Experimental | 110mg PO once daily Receives: Drug: HS-10296 |
| Gefitinib | Active comparator | 250mg PO once daily Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS was defined as the time from the date of first dose until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by investigators. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, approximately 2 years.
Secondary outcomes (7)
Percentage of Participants With 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. Target lesions and assessed by CT per RECIST v1.1 (Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.).
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study.（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: From baseline, then every 6 weeks, until disease progression or discontinuation from study. (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 baseline, then every 6 weeks, until disease progression or discontinuation from study.
Assess the Anti-tumor Activity: Depth of Response (DepOR)
DepOR is defined as the percentage change in tumor shrinkage, based on longest diameter or reconstructed volume, observed at the lowest point (nadir) compared with baseline.
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study.（up to 24 months）
Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs)
Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.
Measured: Continuously throughout the study until 28 days after HS-10296 discontinuation.From first dose of study drug up to 28 days after last dose of study drug taken (up to data cut-off (15 Jan 2021)),approximately 2 years.
Number of Participants With Dose Interruptions
Participants had at least one delay in planned treatment due to treatment emergent adverse events.
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)
Number of Participants With Dose Reductions
Participants had at least one reduction in planned treatment dosage due to treatment emergent adverse events. Every participant took 2 pills of HS
-10296 + 1 pill of placebo(experimental arm) or 2pills of placebo + 1pill of Gefitinib (control arm). When a dose reduction was decided by INV, the set of "2 pills of placebo" was decreased resulting in no reduction of active compound in control arm, compliance with dose modification for AEs in Gefitinib's label which includes interruption, discontinuation but reduction.
Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Feb 2019
- Primary completion15 Jan 2021
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maniam Ajit, MD, Study chair, Pacific Cancer Medical Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849768
- Sponsor's protocol ID
- HS-10296-03-01
- Status last verified
- Oct 2022
- First submitted
- 23 Nov 2018
- Last updated
- 20 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lu S, Dong X, Jian H, Chen J, Chen G, Sun Y, Ji Y, Wang Z, Shi J, Lu J, Chen S, Lv D, Zhang G, Liu C, Li J, Yu X, Lin Z, Yu Z, Wang Z, Cui J, Xu X, Fang J, Feng J, Xu Z, Ma R, Hu J, Yang N, Zhou X, Wu X, Hu C, Zhang Z, Lu Y, Hu Y, Jiang L, Wang Q, Guo R, Zhou J, Li B, Hu C, Tong W, Zhang H, Ma L, Chen Y, Jie Z, Yao Y, Zhang L, Weng J, Li W, Xiong J, Ye X, Duan J, Yang H, Sun M, Wei H, Wei J, Zhang Z, Wu Q. Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS). Cancer Commun (Lond). 2024 Sep;44(9):1005-1017. doi: 10.1002/cac2.12594. Epub 2024 Jul 17.
PubMed 39016053Lu S, Dong X, Jian H, Chen J, Chen G, Sun Y, Ji Y, Wang Z, Shi J, Lu J, Chen S, Lv D, Zhang G, Liu C, Li J, Yu X, Lin Z, Yu Z, Wang Z, Cui J, Xu X, Fang J, Feng J, Xu Z, Ma R, Hu J, Yang N, Zhou X, Wu X, Hu C, Zhang Z, Lu Y, Hu Y, Jiang L, Wang Q, Guo R, Zhou J, Li B, Hu C, Tong W, Zhang H, Ma L, Chen Y, Jie Z, Yao Y, Zhang L, Jie W, Li W, Xiong J, Ye X, Duan J, Yang H, Sun M, Sun C, Wei H, Li C, Ali SM, Miller VA, Wu Q. AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations. J Clin Oncol. 2022 Sep 20;40(27):3162-3171. doi: 10.1200/JCO.21.02641. Epub 2022 May 17.
PubMed 35580297
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Controlled, Double-Blind, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of HS-10296 Versus Gefitinib as First-Line Therapy for Locally Advanced or Metastatic NSCLC With EGFR Sensitizing Mutations
- ClinicalTrials.gov ID
- NCT03849768
- Acronym / sponsor ID
- HS-10296-03-01
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 20 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled, double-blind, multicenter, phase III clinical study.
Detailed description
This is a randomized, controlled, double-blind, multicenter, phase III clinical trial, evaluating the efficacy and safety of HS-10296 compared to gefitinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor sensitizing mutations (EGFRm+) who have not received systemic therapy. Patients are randomly assigned to an HS-10296 treatment group or a gefitinib treatment group at a ratio of 1:1 and receive a once-daily oral dose of HS-10296 or gefitinib, in order to compare the efficacy and safety of the two different treatment regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10296 | Experimental | Drug: HS-10296110mg PO once daily |
| Gefitinib | Active comparator | Drug: Gefitinib250mg PO once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Any patient who meets all of the following inclusion criteria will qualify for entry into the study:
- Provision of informed consent prior to any study specific procedures, sampling and analyses.
- Male or female, age at least 18 years.
- Pathologically confirmed locally advanced or metastatic NSCLC (e.g. this may occur systemic recurrence after prior surgery for early stage disease or patients may be newly diagnosed with stage IIIB/IV disease). Patients must be treatment-naïve for locally advanced or metastatic NSCLC. Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) provided all other entry criteria are satisfied.
- The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either or in combination with other EGFR mutations assessed by central testing using tumour tissue sample or blood sample.
Key exclusion criteria (32 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:
- Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug.
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study treatment.
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 |
|---|---|---|
| HS-10296Also: Investigational ProductDrug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. | Drug | HS-10296 |
| GefitinibAlso: Comparator ProductDrug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria. | Drug | Gefitinib |
Primary outcome
Progression Free Survival (PFS)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, approximately 2 years.
PFS was defined as the time from the date of first dose until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by investigators. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
7 secondary outcomes
Percentage of Participants With Objective Response Rate (ORR)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study.（up to 24 months）
Assess the Anti-tumor Activity: Duration of Response (DoR)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)
Assess the Anti-tumor Activity: Disease Control Rate (DCR)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study.
Assess the Anti-tumor Activity: Depth of Response (DepOR)
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study.（up to 24 months）
Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time frame: Continuously throughout the study until 28 days after HS-10296 discontinuation.From first dose of study drug up to 28 days after last dose of study drug taken (up to data cut-off (15 Jan 2021)),approximately 2 years.
Number of Participants With Dose Interruptions
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)
Number of Participants With Dose Reductions
Time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. (up to 24 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39016053Lu S, Dong X, Jian H, Chen J, Chen G, Sun Y, Ji Y, Wang Z, Shi J, Lu J, Chen S, Lv D, Zhang G, Liu C, Li J, Yu X, Lin Z, Yu Z, Wang Z, Cui J, Xu X, Fang J, Feng J, Xu Z, Ma R, Hu J, Yang N, Zhou X, Wu X, Hu C, Zhang Z, Lu Y, Hu Y, Jiang L, Wang Q, Guo R, Zhou J, Li B, Hu C, Tong W, Zhang H, Ma L, Chen Y, Jie Z, Yao Y, Zhang L, Weng J, Li W, Xiong J, Ye X, Duan J, Yang H, Sun M, Wei H, Wei J, Zhang Z, Wu Q. Central nervous system efficacy of aumolertinib versus gefitinib in patients with untreated, EGFR-mutated, advanced non-small cell lung cancer: data from a randomized phase III trial (AENEAS). Cancer Commun (Lond). 2024 Sep;44(9):1005-1017. doi: 10.1002/cac2.12594. Epub 2024 Jul 17.
- Derived from this study: PubMed 35580297Lu S, Dong X, Jian H, Chen J, Chen G, Sun Y, Ji Y, Wang Z, Shi J, Lu J, Chen S, Lv D, Zhang G, Liu C, Li J, Yu X, Lin Z, Yu Z, Wang Z, Cui J, Xu X, Fang J, Feng J, Xu Z, Ma R, Hu J, Yang N, Zhou X, Wu X, Hu C, Zhang Z, Lu Y, Hu Y, Jiang L, Wang Q, Guo R, Zhou J, Li B, Hu C, Tong W, Zhang H, Ma L, Chen Y, Jie Z, Yao Y, Zhang L, Jie W, Li W, Xiong J, Ye X, Duan J, Yang H, Sun M, Sun C, Wei H, Li C, Ali SM, Miller VA, Wu Q. AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations. J Clin Oncol. 2022 Sep 20;40(27):3162-3171. doi: 10.1200/JCO.21.02641. Epub 2022 May 17.
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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.
Maniam Ajit, MD study chair
Pacific Cancer Medical Center, Inc.
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 HS-10296 and Gefitinib 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 14 inclusion and 32 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 20 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) (time frame: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, approximately 2 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 NCT03849768, which also lists 2 linked publications.
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 20 Jan 2023.