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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.

Study acronym: REZILIENT2
StatusRecruiting
PhasePhase 2
Started2023-07-31
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 80 sites
2026-06-25
Study Status, Contacts/Locations v21
Study sitesdetails revised at 2 of 80 sites
2026-05-27
Study Status, Contacts/Locations v20
Study sitesdetails revised at 3 of 80 sites
2026-04-02
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 80 sites
2026-03-09
Study Status, Study Design, Contacts/Locations v18
Enrollment target324→220
Study sites80 entries, revised
Comprehensive Cancer Centers of Nevada - Central Valley - Twain Virginia Cancer SpecilalistSpecialists Hôpital Nord de Marseille
Show 17 earlier versions
2026-02-05
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v17
Primary completion date2026-02-28→2028-08-31
Completion date2026-08-31→2028-12-31
Enrollment target224→324
Study arms6→8
Eligibility criteria+1,149 characters
[...] ith no history of uncontrolled seizures. ECOG PS of 0 or 1. Dose Optimization Substudy: Has pathologically confirmed, locally advanced or metastatic NSCLC meeting all the following criteria: Documented EGFR ex20ins status, as determined by local testing performed at a CLIA certified (US) or locally certified laboratory (outside the US) Progressed on or after [...] Exclusion Criteria: Participant is currently receiving an in [...] pant has received Zipalertinib (TAS6417/CLN081) at any time ThoracicCNS radiotherapy ≤28 days or palliative radiation (gamma knife radiotherapy is allowed) ≤ 12 weeks, thoracic rad [...] [...]
Secondary endpoints17 to 29 entries
Dose Optimization Substudy: Duration of Response (DoR) as Assessed by BICR and Investigator Dose Optimization Substudy: Time to Response as Assessed by BICR and Investigator Dose Optimization Substudy: Percent Change in Tumor Size From Baseline as Assessed by BICR and Investigator Dose Optimization [...]
Primary endpoints1 to 2 entries
Dose Optimization Substudy: ORR as Assessed by Blinded Independent Central Review (BICR)
Study description+532 characters
[...] dermal Growth Factor Receptor Proteins Mutations (EGFRmts). Additionally,The drug-drug interaction (DDI) substudy will assess the potent [...] ertinib concentration and QT interval change from baseline. Additionally, dose optimization substudy will be conducted to confirm an optimized dose of zipalertinib monotherapy. Participants will be enrolled into 1 of the 4 following coho [...] r cocktail in combination with zipalertinib at steady state. For dose-optimization substudy, participants with locally advanced or metastatic NSCLC harboring epidermal growth factor receptor protein ex20ins mutations (EGFRmts) [...]
2025-10-01
Study Status, Contacts/Locations v16
Study sites79→80
2025-08-12
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v15
Enrollment target220→224
Study sites99→79
Study arms4→6
InterventionsTAS6417 (Drug)→CYP Cocktail (Drug), TAS6417 (Drug), Transporter Cocktail (Drug)
Eligibility criteria+1,849 characters
[...] rug and for 1 month after the last dose of study treatment. DDI Substudy: Participant has pathologically confirmed, locally advanced or metastatic NSCLC: a. Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendments (CLIA) certified (US) or locally certified laboratory (outside of the US) local laborator [...] Exclusion Criteria: PatientParticipant is currently receiving an investigational drug in a clinica [...] of the following within the specific time frame specified: PatientParticipant has received Zipalertinib (TAS6417/CLN081) at any time Thor [...] ass. [...]
Secondary endpoints13 to 17 entries
AllCohorts Cohorts1-4: Number of Participants With Treatment Emergent Adverse Eve [...] nology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) AllCohorts Cohorts1-4: Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters AllCohorts Cohorts1-4: Number of Participants with Clinically Significant Changes in Vital Signs AllCohorts Cohorts1-4: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Parameters AllCohorts Cohorts1-4: Number of participants With Change in Left Ventricular Eje [...] ocardiography (ECHO) and Multigated Acquisiti [...]
Primary endpoints1 entry, revised
AllCohorts Cohorts1-4: Objective Response Rate (ORR)
Study description+860 characters
[...] dermal Growth Factor Receptor Proteins Mutations (EGFRmts). Additionally, drug-drug interaction (DDI) substudy will assess the potential DDI effects of zipalertinib on the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates and transporter substrates and also evaluate the relationship between zipalertinib concentration and QT interval change fro [...] Participants will be enrolled into 1 of the 4 following coho [...] rapy for their locally advanced or metastatic NSCLC disease. For DDI substudy, participants will be enrolled in two groups: CYP Cocktail Group will receive a single dose of cocktai [...]
2025-05-30
Study Status, Study Design v14
Start date2023-07-27→2023-07-31
Enrollment target160→220
2025-04-22
Study Status, Contacts/Locations v13
Study sites117→99
2025-03-07
Active, Not Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v12
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2025-06-30→2026-02-28
Completion date2025-10-20→2026-08-31
Study sites89→117
Eligibility criteria+1,649 characters
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 patientsparticipants: Documented EGFR ex20ins mutation status, as determined by local testing performed at a Clinical Laboratory Improvement Amendments (CLIA) certified (United States [US]) or locally certified laboratory (outside the US). Progress [...] m-based chemotherapy for the treatment of advanced disease. PatientsParticipants who disconti [...] [...]
Secondary endpoints9 to 13 entries
All Cohorts: TheNumber rateof Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) All Cohorts: Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters All Cohor [...] and severityMultigated ofAcquisition treatment(MUGA) emergentScan All AEs Cohorts: Progression-free survival (PFS) Cohort C: intracranialIntracranial durationDuration of completeComplete responseResponse (iDCR) Cohort C: intracranialIntracranial durationDuration of Respon [...] [...]
Primary endpoints1 entry, revised
All Cohorts: objectiveObjective responseResponse rateRate (ORR)
Study description+300 characters
This study will evaluate the safety and efficacy of zipalertinib in patientsparticipants with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations or other uncommon/single or compound EGFRmtEpidermal Growth Factor Receptor Proteins Mutations (EGFRmts). PatientsParticipants will be enrolled into 1 of the 4 following cohorts: Cohort A ("prior ex20ins treatment") will include patientsparticipants harboring EGFR ex20ins mutations who have progressed on or after initial treatment with stan [...] ard platinum-based chemotherapy and prior treatment with an ex20ex20ins agent for their advanc [...] [...]
2025-01-05
Study Status v11
Re-verified, no change to tracked fields
2024-11-29
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Study sites116→89
2024-09-30
Study Status, Contacts/Locations v9
Study sitesdetails revised at 3 of 116 sites
2024-08-30
Study Status, Contacts/Locations v8
Study sitesdetails revised at 38 of 116 sites
2024-06-25
Study Status, Contacts/Locations v7
Re-verified, no change to tracked fields
2024-05-16
Study Status, Contacts/Locations v6
Study sites118→116
2024-05-02
Study Status, Contacts/Locations v5
Study sites115→118
2024-02-28
Study Status, Contacts/Locations v4
Study sites109→115
2024-01-11
Study Status, Contacts/Locations v3
Study sites102→109
2023-11-28
Study Status, Contacts/Locations v2
Study sites1→102
2023-08-21
Study Status v1
Start date2023-07-07→2023-07-27
2023-07-21
Original filing
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.
Trial Details
NCT Number NCT05967689
Lead Sponsor Taiho Oncology, Inc.
Conditions Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
Enrollment 220 participants
Start Date 2023-07-31
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-01