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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    334
  • sponsor
    Jiangsu Aosaikang Pharmaceutical Co., Ltd.
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Updated on 26 May 2022
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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

Details
Condition Locally Advanced or Metastatic NSCLC
Treatment Gefitinib, Placebo Gefitinib 250 mg, Gefitinib 250 mg, ASK120067, ASK120067 + placebo, Gefitinib + placebo ASK120067, Placebo ASK120067
Clinical Study IdentifierNCT04143607
SponsorJiangsu Aosaikang Pharmaceutical Co., Ltd.
Last Modified on26 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female, aged at least 18 years
Pathologically confirmed adenocarcinoma of the lung
Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status
Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents)
Provision of informed consent prior to any study specific procedures, sampling, and analysis
ECOG score of 0 to 1

Exclusion Criteria

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 receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4
Alternative anti-cancer treatment
Treatment with an investigational drug within five half-lives of the compound or any of its related material
Spinal cord compression, symptomatic and unstable brain metastases, except for those
patients who have completed definitive therapy, are not on steroids, have a
stable neurologic status for at least 2 weeks after completion of the
definitive therapy and steroids
、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:Mean resting corrected QT interval (QTc) >470 msec
obtained from 3 ECGs, using the screening clinic ECG machine-derived QTcF value.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
、Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required
steroid treatment, or any evidence of clinically active ILD
、Involvement in the planning and/or conduct of the study
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