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A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection

Study acronym: REZILIENT4
StatusActive, Not Recruiting
PhasePhase 3
Started2025-12-22
View on ClinicalTrials.gov ↗

Amendment history

2026-08-24
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v11
InterventionsCarboplatin (Drug), Cisplatin (Drug), Pemetrexed (Drug), TAS6417 (Drug), Zipalertinib Matching-placebo (Drug)→TAS6417 (Drug), Zipalertinib Matching-placebo (Drug)
Eligibility criteria-211 characters
[...] er uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) exons 18-21 of the EGFR tyrosine kinase domain Baseline imaging assessment of the brain (MRI [preferred modality] or CT scan) performed within 8 weeks prior to randomization [...] ecovery from surgery, including post-operative wound healing, and prior adjuvant chemotherapy (if applicable) at the time of randomization. Randomization musttiming occuris betweendefined as follows: For participants without prior adjuvant chemotherapy: 4 weeks and 12 weeks following surgery. For participants with prior adjuvant chemotherapy: 4 weeks and 8 weeks a [...] [...]
Secondary endpointsdetails revised at 2 of 11 entries
Study description-322 characters
This study will evaluate zipalertinib, a novel EGFR tyrosine kinase inhibitor (TKI) in combination with standard platinum-based adjuvant chemotherapy versus placebo in combination with chemotherapy in participants with resected early stage IB-IIIA NSCLC harboring uncommon EGFRmt. Approximately 360 participants will be randomized to: Arm A: Platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed) in combination with zipalertinibZipalertinib twice daily (BID), followed by zipalertinib alonemonotherapy OR Arm B: Platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed) [...] [...]
Study sitesdetails revised at 51 of 252 sites
Study title-52 characters
A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Early Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
2026-06-25
2 amendments v9-v10
2 re-verifications since 2026-05-27, no change to tracked fields
2026-04-30
Study Status, Contacts/Locations v8
Study sites252 entries, revised
4Warmińsko-mazurskie WojskowyCentrum SzpitalChorób KlinicznyPłuc zw Polikliniką SP ZOZOlsztynie
2026-04-22
Study Status, Contacts/Locations v7
Trial status changed: Recruiting → Active, Not Recruiting
Study sites253→252
2026-04-06
Study Status, Contacts/Locations v6
Trial sites expanded: 214 → 253 locations
Study sitesdetails revised at 1 of 253 sites
Show 5 earlier versions
2026-03-31
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v5
Study sites214→253
Eligibility criteria-79 characters
[...] r uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) Magnetic resonanceBaseline imaging (MRI) or computed tomography (CT) scanassessment of the brain done prior to surgery. Participants in whom this was not done prior to surgery may still be enrolled if appropriate imaging (i.e., MRI or CT of the brainscan) isperformed performedwithin 8 weeks prior to randomization. must show no evidence of brain metastasis Complete surgical resection of the primary NSCLC is mandatory. All grosswith disease must have been removed at the end of surgery. Allnegative surgical margins ofand resectionsystema [...] [...]
Secondary endpointsdetails revised at 2 of 11 entries
Study description-86 characters
[...] n EGFRmt. Approximately 360 participants will be randomized 1:1 to: Arm A: Platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed) in combination with zipalertinib 100 milligrams (mg) twice daily (BID), followed by zipalertinib 100 mg BID alone OR Arm B: Platinum-based chemotherapy (cisplatin or ca [...] ombination with placebo BID, followed by placebo BID alone. The duration of 1 treatment cycle will be 21 days. An independent data monitoring committee (IDMC) will be established to monitor interim safety data.
2026-02-02
Study Status, Contacts/Locations v4
Start dateestimated 2025-11→confirmed 2025-12-22
Study sitesdetails revised at 23 of 214 sites
2025-12-24
Study Status, Contacts/Locations v3
Study sites209→214
2025-10-30
Study Status, Contacts/Locations v2
Primary completion date2029-10→2029-10-01
Completion date2032-10→2032-10-01
Start date2025-08-28→2025-11
Study sitesdetails revised at 2 of 209 sites
2025-09-09
Not Yet Recruiting→Recruiting Study Status, Study Description, Conditions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10→confirmed 2025-08-28
Study sites0→209
2025-08-11
Original filing
The purpose of this study is to compare the efficacy of zipalertinib versus placebo in participants with early stage resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
Trial Details
NCT Number NCT07128199
Lead Sponsor Taiho Oncology, Inc.
Conditions Lung Cancer, Adjuvant, Post-surgical, EGFR, Exon 20, Early Stage Lung Cancer, Uncommon EGFR Mutations, NSCLC, Early Stage
Enrollment 360 participants
Start Date 2025-12-22
Primary Completion 2029-10-01 (estimated)
Study Completion 2032-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-26