A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growt… (NCT05967689) | Clinical Trial Compass
RecruitingPhase 2
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.
United States220 participantsStarted 2023-07-31
Plain-language summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.
Who can participate
Age range18 Years
SexALL
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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:
✓. Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (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). Participants 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 participants 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).
Exclusion criteria
✕. Participant 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.
✕
What they're measuring
1
Cohorts 1-4: Objective Response Rate (ORR)
Timeframe: Up to approximately 2 years
2
Dose Optimization Substudy: ORR as Assessed by Blinded Independent Central Review (BICR)
. Has received any of the following within the specific time frame specified:
✕. Participant has received Zipalertinib (TAS6417/CLN081) at any time
✕. CNS radiotherapy (gamma knife radiotherapy is allowed) ≤ 12 weeks, thoracic radiotherapy ≤ 28 days, or other palliative radiation ≤ 14 days prior to the first dose of study
✕. Anticancer immunotherapy ≤28 days prior to the first dose of study treatment
✕. Major surgery (excluding placement of vascular access) ≤28 days prior to the first dose of study treatment.
✕. Any prior treatment with an EGFR exon20ins- targeted TKI
✕. Participants with leptomeningeal CNS disease.