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Non-small Cell Lung CancerPhase 2NCT05662813

Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

A Phase 2 study testing Almonertinib in people with Non-small Cell Lung Cancer, run by West China Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

To assess the efficacy and safety of Almonertinib therapy in patients with abnormal liver function after first/second generation EGFR-TKI treatment, or Almonertinib first-line therapy in patients with basic hepatopathy and locally advanced or metastatic EGFR-mutant non-small cell lung cancer. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteChina
Study dates
9 Nov 2022to 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at least 18 years.
  • Locally advanced (IIIB and IIIC) or metastatic (IV) NSCLC.
  • Tumor tissue samples or blood samples are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations).
  • Patients have been treated with one kind of EGFR-TKIs and suffered from drug-induced liver injury, and have stopped EGFR-TKIs treatment before enrollment; or patients with basic hepatopathy (alcoholic liver disease, viral liver disease, metabolism related fatty liver disease, autoimmune liver disease, genetic metabolic liver disease), and patients can be treated with EGFR-TKIs after medical specialist evaluation, and no longger treated with hepatoprotective drugs (anti-inflammatory drugs, liver cell membrane repair protective agents, detoxification drugs, antioxidant drugs, cholagogic drugs) for 4 weeks before enrollment.
  • ALT and AST ≤ 3 ULN, Child-Pugh grade A or B (≤ 9 points), and maintained for 4 weeks before enrollment (liver function evaluation criteria according to CTCAE 5.0) .
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3, and has not deteriorated at least 2 weeks, and the expected survival period is not less than 12 weeks.
  • According to RECIST1.1, the patient has at least one intracranial target lesion and one extracranial target lesion. The requirements for target lesions are: measurable lesions that have not undergone local treatment such as irradiation or have clearly progressed after local treatment, with the longest diameter at baseline ≥10 mm (if it is a lymph node, the maximum short diameter is required to be ≥15 mm).

Who cannot join

  • As judged by the investigator, patients with any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active bleeding-prone constitution, or active infection.
  • Patients with any other malignant tumor in the past 5 years.
  • Patients with prior drug-induced liver injury other than EGFR-TKIs.
  • Patients with refractory nausea, vomiting or chronic gastrointestinal diseases, cannot swallow the study drug or who have received extensive intestinal resection, may affect the full absorption of Almonertinib.
  • A history of interstitial lung disease, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.
  • Before Almonertinib treatment, patients with unresolved residual toxicity from previous anti-tumor therapy greater than CTCAE level 3, except for hair loss.
Show all 23Show fewer
  • Meet any of the following cardiac examination results:
  • The average value of QT interval (QTcF) corrected by Fridericia's formula obtained from 3 ECG examinations at rest> 470 msec;
  • Resting ECG suggests that there are various clinically significant rhythms, conduction or ECG morphological abnormalities that are judged by the investigator (such as complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrium Ventricular block and PR interval> 250 msec, etc.);
  • There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT of immediate family members under 40 Any concomitant drugs in the interval;
  • Left ventricular ejection fraction (LVEF) <50%.
  • Insufficient bone marrow reserve or organ function, reaching any one of the following laboratory limits (no corrective treatment within 1 week before laboratory examination of blood draw):
  • Absolute neutrophil count <1.5×109 / L;
  • Platelet count <100×109 / L;
  • Hemoglobin <90 g/L (<9 g/dL);
  • Creatinine>1.5×ULN and creatinine clearance rate<50 mL/min (calculated by Cockcroft-Gault formula); Only when creatinine>1.5×ULN, creatinine clearance rate needs to be confirmed;
  • Serum albumin (ALB) <28 g/L.
  • Female with positive blood or urine pregnancy test results during lactation or within 3 days before the first administration of the study treatment.
  • Active fungal, bacterial and/or viral infections requiring systemic treatment.
  • Have a history of hypersensitivity to any active or inactive ingredients of Almonertinib or to drugs with similar chemical structure to Almonertinib or the same class of Almonertinib.
  • Patients with decompensated cirrhosis, hepatic encephalopathy, hepatorenal syndrome, esophageal and gastric varices bleeding, and intractable ascites.
  • Patients have treated with other three generations of EGFR-TKIs.
  • Patients with any serious or uncontrolled disease, investigator judged that there are any patients with conditions that endanger the safety of the patient or interfere with the evaluation of the study.

Trial locations and contacts

1 site in 1 country.

Feng Luo, doctor contact

18980601766

hxluofeng@163.com

Yanyang Liu contact

13668284452

lyy3346@126.com

China1 site, 1 recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

    Feng Luo

    Recruiting

Other trials in China

About this study

Official title: a Phase II Studay to Assess the Efficacy and Safety of Almonertinib Therapy in Patients With Abnormal Liver Function After First/Second Generation TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

To assess the efficacy and safety of Almonertinib therapy in patients with abnormal liver function after first/second generation EGFR-TKI treatment, or Almonertinib first-line therapy in patients with basic hepatopathy and locally advanced or metastatic EGFR-mutant non-small cell lung cancer.

Read the detailed description

This is a single arm, open-lable, phase II clinical trial，aimed to assess the efficacy and safety of Almonertinib therapy in EGFR-mutant advanced non-small cell lung cancer patients with abnormal liver function after the first/second generation EGFR-TKI treatment or EGFR-mutant advanced non-small cell lung cancer patients with basic hepatopathy and have not received any systematic treatment. The patients meet all the inclusion criterias, and do not meet any exclusion criteria can be included, the duration of patient observation is 24 months.

Being tested
Almonertinib
Keywords
EGFR, NSCLC, abnormal liver function, hepatopathy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Liver Diseases, Digestive System Diseases

What participants receive

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

  • AlmonertinibDrug

    Also called HS-10296

    Almonertinib 110mg p.o qd. Patients receive Almonertinib treatment until disease progression, unacceptable toxicity or other discontinuation criteria.

Study groups in NCT05662813
Study groupRoleWhat they receive
AlmonertinibExperimentalAlmonertinib 110 mg，orally once a day. Patients receive Almonertinib treatment until disease progression, unacceptable toxicity or other discontinuation criteria.
Receives: Drug: Almonertinib

What is being measured

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

  1. Objective response rate

    ORR is defined as the number of patients with at least 1 visit response of CR (Complete response) or PR (Partial response) according to RECIST 1.1.

    Measured: 24 months.

Secondary outcomes (4)

  1. Liver Safety

    Liver function indicators, including ALT, AST, TBIL, D-BIL, I-BIL, ALP, GGT, bile acid, ALB, GLB.

    Measured: From the screening period to 28 days after treatment completion.

  2. Progression-free survival

    PFS is defined as the time from date of enrollment until the date of disease progression as assessed according to RECIST 1.1 or death from any cause on study.

    Measured: 24 months.

  3. Disease control rate

    Disease control rate (DCR) is defined as the percentage of participants with disease control best overall response (complete response, partial response or stable disease).

    Measured: 24 months.

  4. Overall survival

    OS is defined as time from date of enrollment until date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.

    Measured: From baseline until death due to any cause,up to a maximum of approximately 4 years.

Timeline

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

  1. First posted23 Dec 2022
  2. Study start9 Nov 2022
  3. Primary completion30 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
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05662813
Sponsor's protocol ID
2022 Annual Review No.746
Status last verified
Dec 2022
First submitted
7 Dec 2022
Last updated
23 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Almonertinib in people with Non-small Cell Lung Cancer, run by West China Hospital 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 7 inclusion and 23 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 23 Dec 2022. 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 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 Feng Luo, doctor (18980601766, hxluofeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 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 NCT05662813.

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 23 Dec 2022.

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