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.

Conditions

• Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jul 31, 2023

Status verified

May 2026

Primary completion

Aug 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A ("prior ex20ins treatment")
  Cohort A ("prior ex20ins treatment") participants will receive zipalertinib orally twice a day (BID) continuously until documentation of progressive disease (PD) or until other withdrawal criteria are met, whichever comes first.
• Experimental: Cohort B ("first-line treatment")
  Cohort B participants will receive zipalertinib orally, BID continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
• Experimental: Cohort C ("active brain mets")
  Cohort C participants will receive zipalertinib orally, BID continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
• Experimental: Cohort D ("other uncommon EGFRmts").
  Cohort D participants will receive zipalertinib orally, BID continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
• Experimental: DDI Substudy: CYP Cocktail Group
  Participants will receive a 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. Zipalertinib will be dosed, orally BID in Cycle 1 (cycle length = 21 days), followed by continuous treatment with zipalertinib until documentation of PD or until other withdrawal criteria are met, whichever comes first.
• Experimental: DDI Substudy: Transporter Cocktail Group
  Participants will receive a 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. Zipalertinib will be dosed, orally BID in Cycle 1 (cycle length = 21 days), followed by continuous treatment with zipalertinib until documentation of PD or until other withdrawal criteria are met, whichever comes first.
• Experimental: Dose Optimization Substudy: Arm A
  Participants will receive zipalertinib, orally, at Arm A dose, BID, continuously in 21-day treatment cycles until the participant meets any of the treatment discontinuation criteria.
• Experimental: Dose Optimization Substudy: Arm B
  Participants will receive zipalertinib, orally, at Arm B dose, BID, continuously in 21-day treatment cycles until the participant meets any of the treatment discontinuation criteria.

Primary Outcome Measure

Cohorts 1-4: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts

• Taiho Oncology, INC
  +1 844-878-2446
  [email protected]

Locations (18)

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