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Locally Advanced or Metastatic NSCLCPhase 3NCT04143607

ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC

A Phase 3 study testing ASK120067 and Gefitinib in people with Locally Advanced or Metastatic NSCLC, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 3 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To assess the efficacy and safety of ASK120067 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Locally Advanced or Metastatic NSCLC
What is being tested?
ASK120067 and Gefitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
337 participants
Where
3 sitesChina
Study dates
23 Jul 2019to 30 Sep 2026
Phase
Phase 3
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

  • Male or female, aged at least 18 years.
  • Histopathologically or pathologically confirmed adenocarcinoma of the lung.
  • Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy(including those with newly diagnosed or postoperative recurrent stage IIIb, IIIc, or IV cancer).
  • The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R) that have been confirmed by the central laboratory testing report before enrollment (through tissue samples for testing cannot be derived from tumor lesions that have undergone radiotherapy, but can be obtained from newly developed lesions after local treatment) .
  • Patients must be treatment-naïve for locally advanced or metastatic NSCLC (excluding local treatment for non-target lesions) and eligible to receive first-line treatment. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents) if there is no disease progression one year after completion of treatment. Patients who have received local treatment (such as radiotherapy or pleural perfusion therapy) can participate in the study if the lesions covered by local treatment are non-target lesions.
  • At baseline, at least one tumor lesion must meet the following criteria:
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  • It has not been previously treated with radiotherapy and has not been used for biopsy during the screening period; (ii) It can be accurately measured, with the longest diameter of ≥10 mm at baseline (lymph nodes must have a short axis of ≥15 mm); (iii) It can be assessed using both CT and MRI scans, but the same testing method must be used for subsequent evaluations.
  • Expected survival ≥ 3 months.
  • ECOG score of 0 to 1.
  • Reproductive-aged women must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result must be negative.
  • Reproductive-aged women should use strict contraceptive measures throughout the entire trial period and for 3 months after the last administration of the investigational drug. Male subjects should use strict contraceptive measures and should not engage in sperm donation throughout the entire trial period and for 6 months after the last administration of the investigational drug.
  • Provision of informed consent prior to any study specific procedures, sampling, and analysis.

Who cannot join

  • Treatment with any of the following:
  • Prior treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC;
  • Prior treatment with an EGFR-TKI;
  • Major surgery within 4 weeks of the first dose of study drug;
  • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug;
  • Patients currently (within 7 days before the first administration) receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4;
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  • Neoadjuvant and adjuvant therapy (except in cases meeting the inclusion criterion 5);
  • Patients who have received pleural infusion therapy must have stable pleural effusion for 28 days or more before they can be enrolled (intrapleural infusion therapy may use cytokines and immunostimulants, but not biological products or other drugs with long half-lives);
  • Local radiotherapy or palliative radiotherapy for bone metastases within 14 days before the first administration of the investigational drug;
  • Patients are receiving treatment with drugs that are known to prolong the QTc interval or potentially cause torsade de pointes, and require continued treatment with these drugs during the study;
  • Discontinuation of other clinical trial drugs for less than 14 days prior to the first administration.
  • Patients with spinal cord compression or brain/meningeal metastases (except those who are asymptomatic, in stable condition, and do not require treatment with steroids for at least 4 weeks before the start of study treatment; patients who have received local radiotherapy for brain metastases must have remained stable for at least 28 days after radiotherapy before enrollment);
  • 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 ASK120067.
  • Any of the following cardiac criteria:
  • The average corrected (using the Fridericia formula) QT interval (QTcF), obtained from three resting electrocardiogram (ECG) examinations, is greater than 450 ms for males or 470 ms for females;
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;
  • Any patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events 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 ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  • Patients with unrecovered toxic reactions of Grade 2 or above (based on the NCI-CTCAE 5.0 criteria) related to prior treatment at the start of the study treatment (excluding alopecia and Grade 2 neuropathy caused by platinum-based drugs).
  • Patients with mixed lung adenocarcinoma and squamous cell carcinoma.
  • Primary T790M+ patients.
  • Patients with poorly controlled hyperglycemia (when the fasting blood glucose is ≥7.0 mmol/L, the investigators should determine whether it can be stably controlled, and seek consultation with the endocrinology department if necessary).
  • Patients with inadequate bone marrow reserves or other organ dysfunctions, meeting any of the following criteria in laboratory tests (within 2 weeks before the laboratory blood drawing for the enrollment, no blood or blood products are transfused, and no granulocyte colony-stimulating factor or other hematopoietic stimulating factors are used for correction):
  • Absolute neutrophil count<1.5×10^9/L;
  • Platelet count <100 x 10^9/L;
  • Hemoglobin <90 g/L;
  • Alanine aminotransferase (ALT) or as aspartate aminotransferase (AST) levels >2.5 times the upper limit of normal in the absence of definitive hepatic metastases, or >5 times the upper limit of normal in the presence of hepatic metastases;
  • Serum total bilirubin level > 1.5 times the upper limit of normal in the absence of definite hepatic metastases, or > 3 times the upper limit of normal in the presence of definite Gilbert syndrome (unconjugated hyperbilirubinemia) or hepatic metastases;
  • Serum creatinine level >1.5 times.
  • Patients with a history of allergy or hypersensitivity to the active ingredient or inactive excipients of the investigational drug, drugs with chemical structures similar to the investigational drug, or drugs of the same class as the investigational drug.
  • Pregnant and lactating women.
  • Patients with other malignant tumors or diagnosed with other malignant tumors within the past 5 years (excluding clinically cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, and papillary thyroid carcinoma).
  • Patients with any serious or uncontrolled ocular lesion that, in the judgment of the investigator, may bring an increased safety risk to them.
  • Subjects who, in the judgment of investigators, are not suitable for this study.
  • Involvement in the planning and/or conduct of the study.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Chest Hospital,Capital Medical University

    Beijing, Beijing Municipality, 101149

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: A Phase III,Double-Blind, Randomised Study to Assess the Efficacy and Safety of ASK120067 Versus Gefitinib as First-Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

To assess the efficacy and safety of ASK120067 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

Being tested
ASK120067, Placebo Gefitinib 250 mg, Gefitinib, Placebo ASK120067
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.

  • ASK120067Drug

    ASK120067 (80 mg orally twice 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 according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

  • Placebo Gefitinib 250 mgDrug

    Also called Placebo Iressa 250 mg

    The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. 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 according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

  • GefitinibDrug

    Gefitinib (250 mg orally, 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 acording to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

  • Placebo ASK120067Drug

    Placebo ASK120067orally 80mg twice 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 according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

Study groups in NCT04143607
Study groupRoleWhat they receive
ASK120067+ placebo GefitinibExperimentalASK120067 (80 mg orally, twice daily) plus placebo Gefitinib (250 mg orally, once daily), in accordance with the randomization schedule.
Receives: Drug: ASK120067; Drug: Placebo Gefitinib 250 mg
Gefitinib + placebo ASK120067Active comparatorGefitinib (250 mg orally, once daily) plus placebo ASK120067 (80 mg orally, twice daily), in accordance with the randomization schedule.
Receives: Drug: Gefitinib; Drug: Placebo ASK120067

What is being measured

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

  1. Median Progression Free Survival (PFS)

    Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy prior to progression and was used to assess the efficacy of single agent ASK120067 compared with Gefitinib as measured by PFS.

    Measured: CT or MRI at screening and every 2 Cycles until disease progression,date of death or withdrawal from study,whichever came first, assessed up to approximately 2 years

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    ORR was defined as the number (%) of patients with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of ASK120067 compared with Gefitinib defined as the number (%) of patients with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of ASK120067 compared with Gefitinib

    Measured: CT or MRI at screening and every 2 Cycles until disease progression,date of death or withdrawal from study,whichever came first, assessed up to approximately 2 years

  2. Duration of Response (DoR)

    Duration of response was 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 and was used to further assess the efficacy of ASK120067 compared with Gefitinib

    Measured: CT or MRI at screening and every 2 Cycles until disease progression,date of death or withdrawal from study,whichever came first, assessed up to approximately 2 years

  3. Disease Control Rate (DCR)

    The DCR was defined as the percentage of participants who had a best overall response (BOR) of Complete response (CR), Partial response (PR) or Stable disease (SD) ≥6 weeks prior to any Progressive disease (PD) event and was used to further assess the efficacy of ASK120067 compared with Gefitinib

    Measured: CT or MRI at screening and every 2 Cycles until disease progression,date of death or withdrawal from study,whichever came first, assessed up to approximately 2 years

  4. Depth of Response

    The Depth of response was defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions (TLs) at the nadir, in the absence of new lesions (NLs) or progression of Non-target lesions

    Measured: CT or MRI at screening and every 2 Cycles until disease progression,date of death or withdrawal from study,whichever came first, assessed up to approximately 2 years

  5. Overall Survival (OS)- Number of Participants With an Event

    Overall survival was defined as the time from the date of randomisation until death from any cause and was used to further assess the efficacy of ASK120067 compared with Gefitinib

    Measured: Time from treatment start to the time of death due to any cause or withdrawal from study,whichever came first, assessed up to approximately 5 years

Timeline

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

  1. First posted29 Oct 2019
  2. Study start23 Jul 2019
  3. Primary completion31 Mar 2024
  4. Study completion30 Sep 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Triple (Participant, Investigator, Outcomes Assessor)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143607
Sponsor's protocol ID
ASK-LC-120067-F-III
Status last verified
Jun 2024
First submitted
12 Oct 2019
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shi Y, Wu L, Ji Y, Chen G, Li B, Bi M, Yang R, Miao L, Zhang G, Gao H, Sun L, Zhang M, Cang S, Sun M, Yao W, Pan Z, Cui J, Xiao Y, Wang Q; NCT04143607 Study Group. Efficacy and safety of limertinib versus gefitinib as first-line treatment for locally advanced or metastatic non-small-cell lung cancer with EGFR-sensitising mutation: a randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2025 Aug;13(8):677-686. doi: 10.1016/S2213-2600(25)00121-3. Epub 2025 Jun 20.

    PubMed 40550238

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ASK120067 and Gefitinib in people with Locally Advanced or Metastatic NSCLC, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 3 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 12 inclusion and 37 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 14 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 3 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?

Results are not available in the source record.

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?

Median Progression Free Survival (PFS) (time frame: CT or MRI at screening and every 2 Cycles until disease progression,date of death or withdrawal from study,whichever came first, assessed up to approximately 2 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 NCT04143607, 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 14 Jun 2024.

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