Sendai Kousei Hospital | Clinical Trial Management Office
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About
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations.
Full description
This study will evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations or other uncommon/single or compound EGFRmt.
Patients will be enrolled into 1 of the 4 following cohorts:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent
≥18 years of age (or meets the country's regulatory definition of legal adult age, whichever is greater
Pathologically confirmed, locally advanced or metastatic NSCLC meeting all the following criteria:
Cohort A patients:
Cohort B patients:
Cohort C patients:
Documented EGFR ex20ins mutation status, as determined by local testing performed at a CLIA certified (US) or locally certified laboratory (outside the US).
Presence of brain metastasis(es), which may be measurable or nonmeasurable by RANO-BM criteria, characterized as one of the following:
Cohort D patients:
Measurable disease per RECIST 1.1.
Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers (details provided in a laboratory manual). Patients with insufficient tissue may be eligible following discussion with the sponsor.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 17. Adequate organ function, as defined by the hematologic, renal and hepatic laboratory values
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior to administration of the first dose of study treatment. Female patients are not considered to be of childbearing potential if they are post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
Both males and females of reproductive potential must agree to use effective birth control during the study prior to the first dose of study drug and for 6 months after the last dose of study treatment.
Exclusion criteria
Patient is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged to be scientifically or medically incompatible with this study.
Has received any of the following within the specific time frame specified:
Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment, except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the investigator and Sponsor.
Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or evidence of clinically active interstitial lung disease.
Impaired cardiac function or clinically significant cardiac disease including any of the following:
Is unable to swallow tablets/capsules or has any disease or condition that may significantly affect gastrointestinal absorption of zipalertinib (eg, inflammatory bowel disease, malabsorption syndrome, or prior gastric/bowel resection).
History of another primary malignancy ≤2 years prior to the date of first dose of study treatment unless at least one of the following criteria are met:
Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is not controlled with treatment.
History of COVID-19 infection within 4 weeks prior to enrolment and/or has persistent clinically significant pulmonary symptoms related to prior COVID-19 infection.
Active bleeding disorders.
Known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class.
Is pregnant or lactating.
Primary purpose
Allocation
Interventional model
Masking
160 participants in 4 patient groups
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Central trial contact
Taiho Oncology, INC
Data sourced from clinicaltrials.gov
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