Health TrialsbyHealthPanel

A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

ConditionAdvanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Oncology, Inc.

About this trial

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent.

≥18 years of age (or meets the country's regulatory definition of legal adult age, whichever is greater.

Documented EGFR ex20ins status, as determined by local testing performed at a Clinical Laboratory Improvement Amendments (CLIA) certified (United States [US]) or locally certified laboratory (outside the US).

Progressed on or after systemic therapy with an agent targeting ex20ins, either alone or in combination with standard platinum-based chemotherapy for the treatment of advanced disease. Participants who discontinued previous treatment due to unacceptable toxicity are eligible.

Disqualifiers

Participant is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged to be scientifically or medically incompatible with this study.

Participant has received Zipalertinib (TAS6417/CLN081) at any time

CNS radiotherapy (gamma knife radiotherapy is allowed) ≤ 12 weeks, thoracic radiotherapy ≤ 28 days, or other palliative radiation ≤ 14 days prior to the first dose of study

Anticancer immunotherapy ≤28 days prior to the first dose of study treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • TAS6417

    Drug

    Oral tablets

  • CYP Cocktail

    Drug

    Single dose of CYP enzyme probe substrates (CYP cocktail) alone prior to the start of zipalertinib dosing and a single dose of CYP cocktail in combination with zipalertinib at steady state.

  • Transporter Cocktail

    Drug

    Single dose of transporter probe substrates (Transporter cocktail) alone prior to the start of zipalertinib dosing and a single dose of Transporter cocktail in combination with zipalertinib at steady state.

Treatment groups

220 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Cohort A ("prior ex20ins treatment")Experimental treatment 1 intervention
Group B: Cohort B ("first-line treatment")Experimental treatment 1 intervention
Group C: Cohort C ("active brain mets")Experimental treatment 1 intervention
Group D: Cohort D ("other uncommon EGFRmts").Experimental treatment 1 intervention
Group E: DDI Substudy: CYP Cocktail GroupExperimental treatment 2 interventions
Group F: DDI Substudy: Transporter Cocktail GroupExperimental treatment 2 interventions
Group G: Dose Optimization Substudy: Arm AExperimental treatment 1 intervention
Group H: Dose Optimization Substudy: Arm BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cohorts 1-4: Objective Response Rate (ORR)

Time frame
Up to approximately 2 years
2

Dose Optimization Substudy: ORR as Assessed by Blinded Independent Central Review (BICR)

Time frame
Up to approximately 2 years

Secondary outcomes

1

Cohorts 1-4: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)

Time frame
Up to approximately 2 years
2

Cohorts 1-4: Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters

Time frame
Up to approximately 2 years
3

Cohorts 1-4: Number of Participants with Clinically Significant Changes in Vital Signs

Time frame
Up to approximately 2 years
4

Cohorts 1-4: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Parameters

Time frame
Up to approximately 2 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
Apply now