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

Sponsor
Stanford University
Study ID
NCT07802834
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zipalertinib — DRUG
    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.

Study Details

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).

Key Dates

First listed
Sep 3, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm (MRD+)
    Participants will receive adjuvant treatment with zipalertinib up to 3 years
  • No Intervention: Surveillance Arm (MRD-)
    Participants will receive active surveillance up to 3 years

Primary Outcome Measure

Molecular response rate at 12 weeks [ Time Frame: 12 weeks ]

Central Contacts

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