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Lung Cancer Non-small Cell Stage IVPhase 2NCT06463171

Phase II Trial of Almonertinib Plus Lastet for EGFR+ Non-small Cell Lung Cancer

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The goal of this clinical trial is to test in Locally Advanced or Metastatic Non-small Cell Lung Cancer patients with EGFR Mutations. The main question it aims to answer is: Evaluation of the Efficacy and Safety of Aumolertinib in Combination with Lastet for the Treatment of EGFR-Mutated Locally Advanced or Metastatic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer Non-small Cell Stage IV
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
60 participants
Where
2 sitesChina
Study dates
Jun 2024to Jun 2026
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

  • Prior to the implementation of any trial-related procedures, written informed consent must be obtained.
  • Age ≥18 years.
  • Patients with locally advanced (Stage III B/III C), metastatic, or recurrent (Stage IV) non-small cell lung cancer (NSCLC) confirmed histologically or cytologically, who are ineligible for surgical intervention and cannot undergo curative radiochemotherapy, as per the 8th edition TNM staging classification of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer.
  • Provide archived tumor tissue or tissue obtained from biopsy at screening for biomarker testing, including EGFR mutation status, etc.;
  • Presence of EGFR positive mutation;
  • Investigator confirmation of at least one measurable lesion according to RECIST 1.1 criteria.
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  • Patients who have previously received platinum-containing adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy, or radical radiochemotherapy for advanced disease, with disease progression occurring >6 months after the last treatment, may participate in this study;
  • Expected life expectancy ≥3 months.
  • ECOG PS 0-1.
  • Adequate hematologic function, defined as an absolute neutrophil count ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90g/L (without a history of blood transfusion in the past 7 days).
  • Adequate liver function, defined as total bilirubin level ≤1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 times ULN for all patients, or for patients with liver metastasis, AST and ALT levels ≤5 times ULN.
  • Adequate renal function, defined as serum creatinine ≤1.5 times ULN.
  • Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; if a subject is on anticoagulant therapy, INR/PT should be within the therapeutic range set by the anticoagulant.
  • Women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment, with negative results; and reliable contraception methods (such as intrauterine devices, oral contraceptives, and condoms) should be used during the trial and for 30 days after the end of the trial. Men of childbearing potential should use condoms for contraception during the trial and for 30 days after the end of the trial.
  • Willingness to comply with regular follow-up visits and adhere to trial requirements.

Who cannot join

  • 1. Currently participating in an interventional clinical study treatment;
  • Have previously received anti-EGFR treatment;
  • Received traditional Chinese medicine with antitumor indications or immunomodulatory drugs (such as thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose;
  • Have a history of allergic reactions to any of the study drug components.
  • Have active hemoptysis (more than half a teaspoon), active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis;
  • Have tumor compression of surrounding vital organs (such as the esophagus) with accompanying related symptoms, compression of the superior vena cava, or invasion of major mediastinal vessels, the heart, etc.;
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  • Known to have brain metastases. Patients judged by the investigator to be asymptomatic or have stable brain metastases may be enrolled;
  • Have active systemic infections, including tuberculosis (clinical diagnosis including medical history, physical examination, imaging findings, and TB testing according to local medical routines), hepatitis B (known to be HBV surface antigen (HBsAg) positive, with HBV DNA ≥1000cps/ml or the lower limit of the reference value), hepatitis C, or human immunodeficiency virus (HIV antibody positive);
  • Known to have mental illness or substance abuse that may affect compliance with trial requirements;
  • Recently treated with a full dose of oral or non-oral anticoagulants or thrombolytics. Prophylactic use of anticoagulants is allowed.
  • Have a medical history, disease, treatment, or laboratory abnormality that may interfere with the trial results or prevent the subject from participating in the study throughout, or the investigator considers participation in the study not to be in the best interest of the subject.

Trial locations and contacts

2 sites in 1 country.

Jianing Chen contact

18916469896

johnny042018@163.com

China2 sites

  • Zhongshan hospital

    Shanghai, 200032

    Yong Zhang

    Yong Zhang

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

    Feng Ye

    Feng Ye

Other trials in China

About this study

Official title: Phase II Clinical Study of Almonertinib in Combination With Lastet in the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations

The goal of this clinical trial is to test in Locally Advanced or Metastatic Non-small Cell Lung Cancer patients with EGFR Mutations. The main question it aims to answer is:

Evaluation of the Efficacy and Safety of Aumolertinib in Combination with Lastet for the Treatment of EGFR-Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer in First-line Therapy.

Participants will be treated with a combination of Aumolertinib and Lastet.

Being tested
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 Lastet

    Almonertinib, dosing regimen: 110mg/day orally, once daily in a 28-day cycle, continuously.

    Lastet, dosing regimen: 50 mg/day orally, every 28 days in a cycle, two weeks of continuous oral administration, two weeks off.

Study groups in NCT06463171
Study groupRoleWhat they receive
combination therapyExperimentalAlmonertinib, dosing regimen: 110mg/day orally, once daily in a 28-day cycle, continuously. Lastet, dosing regimen: 50 mg/day orally, every 28 days in a cycle, two weeks of continuous oral administration, two weeks off.
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 is defined as the period from the start of treatment until the disease progresses or the patient dies from any cause, whichever came first, assessed up to 24 months

    Measured: up to 24 months

Secondary outcomes (4)

  1. Disease Control Rate

    Disease Control Rate (DCR) is to describe the proportion of patients who have achieved a response to treatment that includes not only complete and partial responses but also stable disease.

    Measured: 24 months

  2. Duration of Response

    The Duration of Response (DoR) is a clinical measure to determine the length of time that a tumor continues to respond to treatment without the cancer worsening.

    Measured: 24 months

  3. Objective Response Rate

    The Objective Response Rate (ORR) is a key metric used in oncology to assess the proportion of patients in a study or treatment group who achieve an objective response (CR or PR).

    Measured: 24 months

  4. Overall Survival

    OS is measured from the date of the initiation of treatment to the date of death from any cause, whichever came first, assessed up to 24 months

    Measured: 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 posted17 Jun 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06463171
Sponsor's protocol ID
2024LY0323
Status last verified
Jun 2024
First submitted
10 Jun 2024
Last updated
17 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In clinical trials, it is essential to strictly protect the privacy of patients' personal information. Data sharing may inappropriately increase the risk of privacy breaches, especially when data anonymization is not handled properly. Additionally, researchers or sponsors, based on their considerations of data ownership and intellectual property rights, have the authority to decide whether and how to share the data.

Publications

  • Chen J, Wang L, Liu L, Zhao J, Wu Y, Yu X, Su C. Aumolertinib in combination with Lastet in the first-line treatment of EGFR-mutated, locally advanced or metastatic non-small cell lung cancer (EVOLUTION): protocol for a single-arm, phase II clinical trial. BMJ Open. 2025 Apr 29;15(4):e097576. doi: 10.1136/bmjopen-2024-097576.

    PubMed 40306921

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Almonertinib in people with Lung Cancer Non-small Cell Stage IV, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 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 15 inclusion and 11 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Jianing Chen (18916469896, johnny042018@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 (time frame: 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 NCT06463171, 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 17 Jun 2024.

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