REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors) (NCT05973773) | Clinical Trial Compass
Active — Not RecruitingPhase 3
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)
United States285 participantsStarted 2023-12-18
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provide written informed consent.
✓. ≥18 years of age (or meets the country's regulatory definition for legal adult age, whichever is greater).
✓. Pathologically confirmed, locally advanced or metastatic nonsquamous NSCLC
✓. Has not received any prior systemic treatment for their locally advanced or metastatic nonsquamous NSCLC. Prior adjuvant/neoadjuvant treatment received \>6 months prior to first dose of study treatment is allowed for early-stage
✓. Treatment duration did not exceed 8 weeks;
✓. Lack of disease response was documented (radiographically) by an increase in tumor burden (a copy of the computerized tomography \[CT\] report showing increase in tumor burden from baseline should be submitted);
✓. Associated toxicities have resolved to baseline; and
✓. The EGFR TKI was discontinued at least 2 weeks or 4 half-lives prior to randomization, whichever is longer.
Exclusion criteria
✕. Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
✕. Prior treatment with any of the following within the specific time frame specified:
✕. Zipalertinib (TAS6417/CLN-081) at any time.
What they're measuring
1
Part A and B: The rate and severity of treatment emergent AEs
Timeframe: approximately 5 years
2
Part A and Part B: Progression-free survival (PFS) by blinded independent central review (BICR)
Timeframe: approximately 5 years
3
Part A: The rate and severity of DLTs according to the NCI-Common Terminology Criteria of Adverse Events (CTCAE) v5.0 during Cycle 1
. Thoracic radiotherapy ≤28 days, palliative radiation of nonthoracic disease ≤14 days, or palliative radiation of a single lesion ≤7 days prior to first dose of study treatment.
✕. Major surgery (excluding placement of vascular access) ≤28 days prior to first dose of study treatment.
✕. All prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications that are strong or moderate CYP3A4 inducers or inhibitors within 7 days prior to first dose.
✕. Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment in the neoadjuvant or adjuvant setting, 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 any evidence of clinically active interstitial lung disease.