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

ConditionsEGFRLung Cancer (NSCLC)Non Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological documentation of NSCLC (squamous histology is permitted).

Clinical or pathological stage IA2 to IIIC or locoregionally recurrent disease based on AJCC 9th edition.

Documented atypical EGFR mutation (defined as non-exon 19 deletion or L858R) including but not limited to exon 20 insertion, E709X, G719X, S768I, L861X, exon 19 insertion, and others (which may be allowed with study PI/Co-PI permission) as demonstrated by a test routinely used by each institution and performed in a CLIA-certified or equivalent laboratory.

Completed all planned curative-intent therapy with surgery and/or radiation. May have received neoadjuvant/adjuvant chemotherapy; but patients that received prior concurrent chemotherapy and radiation are excluded.

Disqualifiers

Any component of small cell lung cancer, for example mixed small cell and non-small cell lung cancer histology.

Tumor harbors a classical EGFR mutation (exon 19 deletion or L858R), even in combination with atypical mutations.

Prior treatment with any EGFR targeting drug, including zipalertinib.

Prior treatment with any adjuvant immune checkpoint inhibitor. Neoadjuvant immune checkpoint inhibitor may be allowed with study PI/Co-PI review and permission.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Treatment Arm (MRD+)Experimental treatment 1 intervention
Group B: Surveillance Arm (MRD-)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Molecular response rate at 12 weeks

To measure the molecular response rate at 12 weeks of adjuvant zipalertinib in the Treatment MRD+ Arm.

Time frame
12 weeks

Secondary outcomes

1

Disease-free survival (DFS)

To evaluate the 3-year disease-free survival (DFS) rate among all participants.

Time frame
3 years
2

Overall survival (OS) rate

To evaluate the 3-year overall survival (OS) rate among all participants.

Time frame
3 years
3

Incidence and Severity of Adverse Events

Number of participants experiencing adverse events and severity of adverse events, graded according to NCI CTCAE v5.0, during treatment with zipalertinib in the MRD+ Treatment Arm.

Time frame
From first dose of zipalertinib through 30 days after the last dose, up to approximately 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Taiho Oncology, Inc.

Collaborator

National Comprehensive Cancer Network

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: