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Non-small Cell Lung CarcinomaPhase 3APEXNCT04762459

Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection

A Phase 3 study testing Almonertinib, Pemetrexed and Cisplatin in people with Non-small Cell Lung Carcinoma, run by Chinese Academy of Medical Sciences at 34 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, randomized, open label, phase III study. Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Non-small Cell Lung Carcinoma
What is being tested?
Almonertinib, Pemetrexed and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
606 participants
Where
34 sitesChina
Study dates
1 Aug 2021to May 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 to 130 years
  • 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 must be classified post-operatively as Stage II-IIIA on the basis of pathologic criteria.
  • 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 randomization.

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 Almonertinib.
  • 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 Almonertinib, or to drugs with a similar chemical structure or class to Almonertinib.
  • Patients who are allergic to pemetrexed or any other ingredients in the preparation, cisplatin or other platinum-containing compounds.
  • Patients with contraindications of pemetrexed and cisplatin.
  • 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

34 sites in 1 country. Contact the study team or a site near you to ask about taking part.

34 sites in 1 country

China34 sites

  • Chinese Academy of Medical Science

    Beijing, Beijing Municipality

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Hunan Cancer Hospital

    Changsha

  • Sichuan Cancer Hospital

    Chendu

  • Sichuan Provincial People's Hospital

    Chengdu

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Fujian Medical University Consonancy Hospital

    Fuzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • The Second Affiliated Hospital of Zhejiang University School Of Medicine

    Hangzhou

  • The First People's Hospital of Yunnan Province

    Kunming

  • Yunnan Cancer Hospital

    Kunming

  • JiangXi Cancer Hospital

    Nanchang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Cancer Hospital

    Nanjing

  • Jiangsu Provincial People's Hospital

    Nanjing

  • Ningbo Medical Center Li Huili Hospital

    Ningbo

  • Qingdao Municipal Hospital

    Qingdao

  • Fudan University Shanghai Cancer Center

    Shanghai

  • ShangHai Chest Hospital ShangHai JiaoTong University

    Shanghai

  • ShangHai Pulmonary Hospital

    Shanghai

  • Liaoning Cancer Hospital

    Shenyang

  • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center

    Shenzhen

  • Hebei Cancer Hospital

    Shijiazhuang

  • West China Hospital，Sichuan University

    Sichuan

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Thoracic Surgery Department Of The ShanXi Provincial Cancer Hospital

    Taiyuan

  • Tianjin Chest Hospital

    Tianjin

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi

  • Weifang People's Hospital

    Weifang

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

  • Wuhan Union Hospital Of China

    Wuhan

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for EGFR Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection: A Multicenter, Randomized Controlled, Open-label Clinical Study

This is a multicenter, randomized, open label, phase III study.

Read the detailed description

This is a multicenter, randomized, open label, phase III study assessing the efficacy and safety of Almonertinib combined with or without chemotherapy as an adjuvant treatment in patients with epidermal growth factor receptor (EGFR) mutation positive stage II-IIIA non-squamous NSCLC following complete tumour resection: Eligible patients will be randomized to receive either Almonertinib alone (110mg, po, once daily) or Almonertinib (110mg, po, once daily) plus pemetrexed (500mg/m2, iv) and cisplatin (500mg/m2, iv) or pemetrexed (500mg/m2, iv) plus cisplatin (500mg/m2, iv) in a 3:2:1 ratio.

Being tested
Almonertinib, Pemetrexed, Cisplatin
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

    Almonertinib 110mg PO once daily

  • PemetrexedDrug

    500 milligrams per square meter (mg/m²) Pemetrexed

  • CisplatinDrug

    75mg/m² Cisplatin taken intravenously (IV) once every 3 weeks concurrently

Study groups in NCT04762459
Study groupRoleWhat they receive
AlmonertinibActive comparatorDrug: Almonertinib 110 mg A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. The overall treatment last for 3 years.
Receives: Drug: Almonertinib
Almonertinib/Pemetrexed/CisplatinExperimentalDrug: Almonertinib 110 mg Drug: Pemetrexed 500 mg/m² IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops. Drug: Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. The overall treatment last for 3 years.
Receives: Drug: Almonertinib; Drug: Pemetrexed; Drug: Cisplatin
Pemetrexed/CisplatinActive comparatorDrug: Pemetrexed 500 mg/m² IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops. Drug: Cisplatin 75mg/m2 IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: The patient continues to receive treatment until the disease progresses or reaches termination criteria. If disease progresses during the treatment period and conditions required for the cross-treatment are met according to the assessment process, the patient can start to receive the open cross-treatment of Almonertinib. The overall treatment last for 3 years.
Receives: Drug: Pemetrexed; Drug: Cisplatin

What is being measured

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

  1. Disease free survival (DFS)

    Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence)

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes (3)

  1. Disease free survival (DFS)

    Defined as the proportion of patients alive and disease free at 2, 3 ,4and 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 randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  2. Overall Survival (OS)

    Defined as the time from the date of randomization 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 100 months

  3. 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 randomization until treatment completion or discontinuation, assessed up to 100 months

Timeline

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

  1. First posted21 Feb 2021
  2. Study start1 Aug 2021
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 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
None (open label)
Enrolment
606 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762459
Sponsor's protocol ID
YX-L-202105
Acronym
APEX
Status last verified
Feb 2021
First submitted
10 Feb 2021
Last updated
24 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Almonertinib, Pemetrexed and Cisplatin in people with Non-small Cell Lung Carcinoma, run by Chinese Academy of Medical Sciences at 34 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 26 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: enrolling by invitation, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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 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?

Disease free survival (DFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 NCT04762459.

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 24 Feb 2022.

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