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NCT05967689 (Zipalertinib in ex20in-mt advanced or metastatic Non-Small Cell…): BVCT ex-ante prediction vs. reported outcome

On 31 Jul 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 9 Sep 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (superior ORR/PFS) and commercially TBD.

Clinical Trial

NCTID
NCT05967689
Acronym
REZILIENT2
Drug Name
Zipalertinib (TAS6417)
Drug MoA
3rd-gen pan-mutant wt-sparing EGFR TKI
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
ex20in-mt advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
Human Patients
224
Sponsor
Taiho Oncology / Cullinan Therapeutics
Phase
Phase 2

Prediction of , index 2051

Prospective Prediction
Prediction Index
2051
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in OS slightly-to-moderately superior to osimertinib for cohort A/B/C/D)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS compared with placebo at least numerically superior to osimertinib for cohort A/B/C/D)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
40 days in advance
Readout Data Interpretation
Zipalertinib achieved a 62.5% ORR for 1L ex20in-mt NSCLC; moderately superior to osimertinib that achieved 25% ORR (see add'l link below); Zipalertinib achieved 21.9% ORR for 2L ex20in-mt NSCLCs; moderately superior to osimertinib that achieved 5% ORR (see DOI-10.1016/j.jtocrr.2022.100459); wait for OS data
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior ORR/PFS) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.
Phase
Phase 2
Status
Recruiting
Enrollment
220
Lead sponsor
Taiho Oncology, Inc.
Conditions
Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
Interventions
DRUG: TAS6417; DRUG: CYP Cocktail; DRUG: Transporter Cocktail
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-07-31
Primary completion
2028-08-31
Completion
2028-12-31
Primary outcomes
  • Cohorts 1-4: Objective Response Rate (ORR) (Up to approximately 2 years)
  • Dose Optimization Substudy: ORR as Assessed by Blinded Independent Central Review (BICR) (Up to approximately 2 years)

NCT05967689 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials