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Pulmonary Adenosquamous CarcinomaPhase 2ARISENCT04354961

Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell Carcinoma

A Phase 2 study testing Almonertinib in people with Pulmonary Adenosquamous Carcinoma, run by Fujian Cancer Hospital at 18 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a prospective, multi-center, single-arm clinical trial. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Adenosquamous Carcinoma
What is being tested?
Almonertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
18 sitesChina
Study dates
7 May 2021to 30 Jun 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 pulmonary adenosquamous carcinoma. Patients must be treatment-naïve for locally advanced or metastatic pulmonary adenosquamous carcinoma. provided all other entry criteria are satisfied.
  • Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.
  • The tumour harbours EGFR genes mutations assessed by central testing using tissue, blood, pleural effusion, peritoneal effusion, and cerebrospinal fluid samples..
  • A WHO performance status equal to 0-2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
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  • 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

  • Treatment with any of the following:
  • 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.
  • 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 with other malignancies requiring standard treatment or major surgery within 2 years after the first dose of study treatment, except basal cell carcinoma and carcinoma in situ.
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  • 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.
  • 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 Almonertinib.
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTc) > 470 ms obtained from 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 Almonertinib or to drugs with a similar chemical structure or class to Almonertinib.
  • 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

18 sites in 1 country.

Gen Lin contact

86+0591-62002057

lingen197505@163.com

18 sites in 1 country

China18 sites, 18 recruiting

  • Beijing Cancer Hospital

    Beijing

    Jun Zhao

    Jun Zhao

    Not yet recruiting

  • Beijing Chest Hospital, Capital Medical University

    Beijing

    Zhe Liu

    Zhe Liu

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Zhijie Wang

    Zhijie Wang

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha

    Lin Wu

    Lin Wu

    Not yet recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha

    Fang Wu

    Fang Wu

    Not yet recruiting

  • Xinqiao Hospital, Army Medical University

    Chongqing

    Bo Zhu

    Bo Zhu

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Lin Gen

    Recruiting

  • Fujian Provincial Hospital

    Fuzhou

    Zhenghua Liu

    Zhenghua Liu

    Not yet recruiting

  • Sir Run Run Shaw Hospital

    Hangzhou

    Yong Fang

    Yong Fang

    Not yet recruiting

  • The second Affiliated Hospital of Kunming Medical University

    Kunming

    Jie Lin

    Jie Lin

    Not yet recruiting

  • The second Affiliated Hospital of Nanchang University

    Nanchang

    Anwen Liu

    Anwen Liu

    Recruiting

  • Jiangsu Province Hospital

    Nanjing

    XiaoFeng Chen

    XiaoFeng Chen

    Not yet recruiting

  • Shanghai Chest Hospital

    Shanghai

    Yongfeng Yu

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Dingzhi Huang

    Recruiting

  • Tongji Hospital of Tongji Medical College,Huazhong University of Science and Technology

    Wuhan

    Qian Chu

    Qian Chu

    Recruiting

  • Air Force Medical University of PLA (the Fourth Military Medical University)

    Xi'an

    Hongmei Zhang

    Hongmei Zhang

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Huijuan Wang

    Huijuan Wang

    Not yet recruiting

  • Henan Provincial People's Hospital

    Zhengzhou

    Shundong Cang

    Shundong Cang

    Not yet recruiting

Other trials in China

About this study

Official title: Aumolertinib as First-line Treatment in EGFR-Mutant Pulmonary Adenosquamous Carcinoma: A Multicenter, Single-Arm, Prospective Study (ARISE)

This is a prospective, multi-center, single-arm clinical trial.

Read the detailed description

This is a multicenter, single arm, phase II study assessing the efficacy and safety of Almonertinib as first-line treatment in patients with EGFR mutation positive locally advanced or metastatic Pulmonary Adenosquamous Carcinoma.

Being tested
Almonertinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlmonertinibDrug

    Also called Investigational Product

    Almonertinib 110mg PO once daily. 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 groups in NCT04354961
Study groupRoleWhat they receive
Almonertinib 110mg PO once dailyExperimentalNot described
Receives: Drug: Almonertinib

What is being measured

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

  1. Progression Free Survival (PFS)

    To assess the efficacy of Almonertinib as first line therapy to EGFRm+, locally advanced or metastatic Pulmonary Adenosquamous Carcinoma patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    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, assessed up to 24 months.

Secondary outcomes (9)

  1. Assess the anti-tumor activity: OS

    Overall survival (OS)

    Measured: Start of study drug to Survival Endpoint through study completion, an average of 4 years.

  2. Assess the anti-tumor activity: ORR

    Objective response rate (ORR)

    Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.

  3. Assess the anti-tumor activity: DCR

    Disease control rate (DCR)

    Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD assessed up to 24 months.

  4. Assess the anti-tumor activity: DoR

    Duration of response (DoR)

    Measured: 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.

  5. Assess the safety of Almonertinib : Number of AEs/SAEs

    Number of adverse events (AEs)/serious adverse events (SAEs)

    Measured: Continuously throughout the study until 28 days after Termination of the treatment

  6. QoL QoL

    To assess disease-related symptoms and QoL in overall population as well as in pre-specified subgroups

    Measured: 2 years

  7. Assess the anti-tumor activity: iORR

    Intracranial Objective response rate (iORR)

    Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.

  8. Assess the anti-tumor activity: iDCR

    Intracranial Disease control rate (iDCR)

    Measured: From baseline, then every 6 weeks, until disease progression or discontinuation from study. ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months.

  9. Intracranial Progression Free Survival (iPFS)

    To assess the efficacy of Almonertinib as first line therapy to EGFRm+, locally advanced or metastatic Pulmonary Adenosquamous Carcinoma patients by assessment of intracranial progression free survival (iPFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    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, assessed 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.

  1. First posted21 Apr 2020
  2. Study start7 May 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Jun 2025 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04354961
Sponsor's protocol ID
HS-LK-2020-003
Acronym
ARISE
Status last verified
Nov 2023
First submitted
17 Apr 2020
Last updated
8 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang L, Huang L, Huang D, Liu Z, Yu Y, Miao K, Miao Q, Zheng X, Xu Y, Chu Q, Lin G. Safety and Efficacy of Aumolertinib as First-Line Treatment in EGFR-Mutant Lung Adenosquamous Carcinoma: A Multicenter, Single-Arm, Prospective Phase II Study (ARISE Study). MedComm (2020). 2026 Jul 22;7(8):e70855. doi: 10.1002/mco2.70855. eCollection 2026 Aug.

    PubMed 42488708

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Almonertinib in people with Pulmonary Adenosquamous Carcinoma, run by Fujian Cancer Hospital at 18 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 28 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 Gen Lin (86+0591-62002057, lingen197505@163.com), or a site near the patient. 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, 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?

On the ClinicalTrials.gov record for NCT04354961, 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 8 Nov 2023.

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