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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

ConditionsLung CancerAdjuvantPost-surgicalEGFRExon 20Early Stage Lung CancerUncommon EGFR MutationsNSCLC, Early Stage
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Oncology, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.

exon20 insertion mutations (ex20ins) or

other 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 must show no evidence of brain metastasis

Disqualifiers

Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research.

Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time.

Pre-operative or post-operative or planned radiation therapy for the current lung cancer.

Any prior systemic anticancer therapy for NSCLC, including preoperative (neoadjuvant) chemotherapy, immunotherapy, or investigational therapy. (Exception: Participants who have received postoperative adjuvant platinum-based chemotherapy up to 4 cycles are permitted)

Trial design

Design model

Parallel

Treatments tested in this trial

  • TAS6417

    Drug

    Oral tablets.

  • Zipalertinib Matching-placebo

    Drug

    Oral tablets.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: ZipalertinibExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free Survival (DFS) as Assessed by the Investigator

Time frame
Up to 5 years

Secondary outcomes

1

Disease-free Survival Rate

Time frame
Up to 5 years
2

Overall Survival (OS)

Time frame
Up to 5 years
3

Overall Survival Rate

Time frame
Up to 5 years
4

DFS of Central Nervous System (cDFS)

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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

Taiho Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov
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