Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05973773 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

Study acronym: REZILIENT3
StatusActive, Not Recruiting
PhasePhase 3
Started2023-12-18
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Oct 29, 2026 → May 27, 2027
See other at-risk trials from Taiho Oncology, Inc.

Amendment history

2026-07-29
Study Status, Contacts/Locations v16
Primary completion pushed: 2026-10-29 → 2027-05-27
Study sitesdetails revised at 35 of 130 sites
2026-05-27
Study Status, Contacts/Locations v15
Study sites128→130
2026-03-06
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v14
Trial statusRecruiting→Active, Not Recruiting
Start date2023-06-30→2023-12-18
Enrollment targetestimated 272→confirmed 285
Study sites131→128
2025-10-30
Study Status v13
Primary completion date2026-07-27→2026-10-29
Completion date2026-08-24→2027-05-27
2025-07-31
Study Status, Contacts/Locations v12
Study sites114→131
Show 11 earlier versions
2025-03-31
Study Status, Contacts/Locations v11
Study sites103→114
2025-01-05
Study Status, Contacts/Locations v10
Study sites92→103
2024-11-29
Study Status, Contacts/Locations v9
Study sites87→92
2024-10-30
Study Identification, Study Status, Conditions, Contacts/Locations, IPDSharing v8
Study sites83→87
Study titlerevised
REZILIENT3 (REsearching ZIpaLertinib inIn Egfr Non-small Cell Lung Cancer Tumors)
2024-09-24
Study Identification, Study Status, Conditions, Contacts/Locations, IPDSharing v7
Study sites82→83
Study titlerevised
REZILIENT3 (REsearching ZIpaLertinib Inin Egfr Non-small Cell Lung Cancer Tumors)
2024-08-30
2 amendments v5-v6
2 re-verifications since 2024-06-25, no change to tracked fields
2024-05-02
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v4
Primary completion date2026-01-30→2026-07-27
Completion date2026-05-21→2026-08-24
Enrollment target312→272
Eligibility criteria+1,696 characters
Inclusion Criteria:- Provide written informed consent. ≥18 years of age (or meet [...] tic nonsquamous NSCLC. Prior adjuvant/neoadjuvant treatment for advanced or metastatic diseasereceived >6 months prior to first dose of study treatment is allowed for early-stage NSCLC. Prior NSCLCmonotherapy with an approved EGFR TKI (ie, gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib) as nonstandard first-line therapy for the treatment of locally advanced or metastatic disease is allowed if all of the following criteria are met: Treatment duration did not exceed 8 weeks; Lack o [...] . Documented EGFR mutat [...] [...]
Study description+211 characters
[...] atin or cisplatin) compared to standard chemotherapy alone. Patients randomized to the chemotherapy-only treatment arm in Part B may receive treatment with zipalertinib as monotherapy after BICR-assessed progressive disease (PD) is documented (optional "crossover arm"). An independent data monitoring committee (IDMC) will be esta [...] dy will begin following completion of Part A. Approximately 300260 patients will be randomized on a 1:1 basis to receive pemet [...]
Study title-111 characters
AREZILIENT3 Study(REsearching ofZIpaLertinib ZipalertinibIn and Chemotherapy Compared With Chemotherapy Alone in Patients With AdvancedEgfr Non-Smallsmall Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFRTumors) Exon 20 Insertion.
2024-04-02
Study Status, Contacts/Locations v3
Study sites71→82
2023-12-05
Study Status, Contacts/Locations v2
Study sites1→71
2023-08-23
Study Status v1
Primary completion date2026-12-30→2026-01-30
Completion date2027-04-21→2026-05-21
Start date2023-06-26→2023-06-30
2023-07-25
Original filing
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.
Trial Details
NCT Number NCT05973773
Lead Sponsor Taiho Oncology, Inc.
Conditions Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation
Enrollment 285 participants
Start Date 2023-12-18
Primary Completion 2027-05-27 (estimated)
Study Completion 2027-05-27 (estimated)
Updated on ClinicalTrials.gov 2026-07-30