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Adjuvant ctDNA-Adapted Treatment With Zipalertinib in Early-Stage Atypical EGFR-Mutant NSCLC

NCT07802834 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-09-03

No results posted yet for this study

Summary

This study will evaluate the novel, oral EGFR TKI, zipalertinib, in the adjuvant ctDNA-adapted treatment of stage IA2 to IIIC atypical EGFR-mutant NSCLC after completion of definitive therapy with a primary endpoint of molecular response in participants identified as having minimal residual disease (MRD).

Conditions

  • EGFR
  • Lung Cancer (NSCLC)
  • Non Small Cell Lung Cancer

Interventions

DRUG

Zipalertinib

Zipalertinib will be administered to participants allocated to the Treatment MRD+ Arm of this study on the basis of MRD positivity at study entry or on repeat assessment. Zipalertinib will begin on Cycle 1 Day 1 and will be self-administered at 100 mg oral (PO) twice daily (BID) every day in each 21-day cycle.

Sponsors & Collaborators

Principal Investigators

  • Joel Neal, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802834 on ClinicalTrials.gov