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Non-small Cell Lung CancerPhase 3NCT04687241

Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations

A Phase 3 study testing Almonertinib in people with Non-small Cell Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To assess the efficacy and safety of Almonertinib versus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm+) stage II-IIIB non-small cell lung cancer (NSCLC), following complete tumor resection with or without adjuvant chemotherapy. 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?
Almonertinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
192 participants
Where
1 siteChina
Study dates
30 Apr 2021to 1 Jan 2029
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 diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.
  • 4. MRI or CT scan of the brain must be done before surgery to exclude brain metastasis.
  • 5. Complete surgical resection of the primary NSCLC and lymphadenectomy are mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor.
  • 6. Patients must be classified post-operatively as Stage IIA, IIB, IIIA or IIIB (only T3N2M0) based on pathologic criteria.
  • 7. Confirmation by the central laboratory that the tumor harbors 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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  • 8. Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
  • 9. A WHO performance status of 0-1 with no deterioration over the past 2 weeks and a minimum life expectancy of 12 weeks.
  • 10. 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. A pregnancy test should be done before first dosing unless having evidence of non-child-bearing potential.
  • 11. Male patients should be willing to use barrier contraception (condoms).

Who cannot join

  • 1. Patients who have had only segmentectomies or wedge resections. 2. Treatment with any of the following:
  • Any prior anticancer therapy for the current lung cancer (pre-operative (neoadjuvant) platinum-based or other chemotherapy, pre-operative or post-operative or planned radiation therapy, neoadjuvant or adjuvant EGFR-TKI, other targeted therapy and immunotherapy).
  • Major surgery (including primary tumor surgery, excluding placement of vascular access) within 3 weeks of the first dose of study drug.
  • Patients currently receiving medications or herbal supplements known to be strong inducers and inhibitors of cytochrome P450 (CYP) 3A4.
  • Treatment with an investigational drug within five half-lives of the compound or any of its related material.
  • 3. Inadequate bone marrow reserve or organ function. 4. Any of the following cardiac criteria:
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  • 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., PR interval > 250 ms).
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure or any concomitant medication known to prolong the QT interval.
  • Left ventricular ejection fraction (LVEF) ≤ 40%. 5. 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.
  • 6. 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)).
  • 7. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow the study drug that would preclude adequate absorption of Almonertinib.
  • 8. History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  • 9. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 except alopecia and Grade 2 prior platinum-therapy related neuropathy.
  • 10. History of hypersensitivity to any active or inactive ingredient of Almonertinib or to drugs with a similar chemical structure or class to Almonertinib.
  • 11. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply 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.

China1 site

  • Jilin Province Cancer Hospital

    Changchun, Jilin, 130000

Other trials in China

About this study

Official title: Efficacy and Safety of Almonertinib Versus Placebo as Adjuvant Therapy for Subjects With Resected Stage II-IIIB NSCLC Harboring EGFR-sensitive Mutations: A Randomized, Controlled, Double-blind, Phase 3 and Multicenter Clinical Study

To assess the efficacy and safety of Almonertinib versus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm+) stage II-IIIB non-small cell lung cancer (NSCLC), following complete tumor resection with or without adjuvant chemotherapy.

Read the detailed description

HS-10296-302 is a randomized, placebo-controlled, double-blind, multicenter, phase III study to assess the efficacy and safety of Almonertinib versus placebo in stage II-IIIB NSCLC with EGFRm+ following complete tumor resection, with or without postoperative adjuvant chemotherapy (2~4 cycles of platinum-based doublet). Eligible patients are randomized to receive either Almonertinib (110 mg orally, once daily) or placebo (110 mg orally, once daily) in a 1:1 ratio.

Being tested
Almonertinib, Placebo Almonertinib
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.

  • AlmonertinibDrug

    Also called HS-10296

    The initial dose of Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions.

  • Placebo AlmonertinibDrug

    Placebo Almonertinib

Study groups in NCT04687241
Study groupRoleWhat they receive
AlmonertinibExperimentalNot described
Receives: Drug: Almonertinib
Placebo AlmonertinibPlacebo comparatorNot described
Receives: Drug: Placebo Almonertinib

What is being measured

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

  1. DFS (Disease free survival) assessed by IRC (Independent Review Committee)

    DFS is defined as the time from randomization to the recurrence of tumor as assessed by IRC or death from any cause on study. The patients will receive long-term follow-up including chest and abdominal CT every 12 weeks during Year 1, then every 24 weeks during Years 2 to 5, and every 48 weeks during Year 6 and onwards; MRI/CT of brain, and bone scan performed every 48 weeks.

    Measured: From the time of randomization to recurrence of tumor or death, approximately 4 years.

Secondary outcomes (6)

  1. DFS (Disease free survival) assessed by INVs (Investigators)

    The patients will receive long-term follow-up including chest and abdominal CT every 12 weeks during Year 1, then every 24 weeks during Years 2 to 5, and every 48 weeks during Year 6 and onwards; MRI/CT of brain, and bone scan performed every 48 weeks. DFS is defined as the time from randomization to the recurrence of tumor as assessed by INVs or death from any cause on study.

    Measured: From the time of randomization to recurrence of tumor or death, approximately 4 years.

  2. DFS rate at 2, 3 and 5 years assessed by IRC

    Defined as the proportion of patients alive and disease free at 2, 3 and 5 years, respectively, estimated from Kaplan Meier plots of the primary endpoint of DFS at the time of the primary analysis.

    Measured: From the time of randomization to recurrence of tumor or death, approximately 6 years.

  3. OS (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 24 weeks after discontinuation of the randomized treatment.

    Measured: The time from randomization to death due to any cause, approximately 8 years.

  4. OS rate at 5 years

    OS rate at 5 years is defined as the proportion of patients alive at 5 years.

    Measured: The time from randomization to death due to any cause, approximately 8 years.

  5. Incidence and severity of adverse events (AEs)

    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.

  6. Plasma concentrations of Almonertinib and HAS-719 metabolite.

    Defined as the pharmacokinetics exposure parameters derived from plasma concentrations of Almonertinib and its metabolite, HAS-719.

    Measured: From Cycle 3 (Each cycle =3 weeks) to Cycle 4, approximately 3 weeks.

Timeline

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

  1. First posted29 Dec 2020
  2. Study start30 Apr 2021
  3. Primary completion8 Jul 2024
  4. Study completion1 Jan 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04687241
Sponsor's protocol ID
HS-10296-302
Status last verified
Nov 2024
First submitted
23 Dec 2020
Last updated
7 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang L, Zhang X, Wu L, Xing W, Liu C, Zhang P, Chen K, Shi J, Xu S, Zhang X, Dong X, Fang H, Yu X, Gao Y, Li G, Chen Z, Fan S, Zhang X, Cheng Y. Aumolertinib as adjuvant therapy in resected EGFR-mutated non-small-cell lung cancer (ARTS): a double-blind, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Feb;27(2):159-168. doi: 10.1016/S1470-2045(25)00643-6. Epub 2026 Jan 12.

    PubMed 41539318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Almonertinib 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 19 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 7 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. Some participants in this study may receive a placebo. 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?

DFS (Disease free survival) assessed by IRC (Independent Review Committee) (time frame: From the time of randomization to recurrence of tumor or death, approximately 4 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 NCT04687241, 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 7 Nov 2024.

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