RECRUITING

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

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Conditions

Advanced or Metastatic NSCLS With Exon 20 Insertion MutationExon 20 insertion mutationNSCLCphase 3Lung diseaseCarcinoma, Non-Small-Cell LungCLN-081TAS6417EGFR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.

Official Title

Randomized, Controlled, Open-label, Phase 3, Global Multi - Center Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy Versus Chemotherapy Alone, in Patients With Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

Quick Facts

Study Start:2023-06-30
Study Completion:2026-08-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05973773

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Taiho Oncology, INC
CONTACT
+1 844-878-2446
medicalinformation@taihooncology.com

Study Locations (Sites)

Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
United States
Comprehensive Cancer Centers of Nevada - Horizon Ridge Henderson
Henderson, Nevada, 89052
United States
Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie
Henderson, Nevada, 89074
United States
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II
Las Vegas, Nevada, 89144
United States
Comprehensive Cancer Centers of Nevada - Southwest
Las Vegas, Nevada, 89148
United States
Comprehensive Cancer Centers of Nevada - Central Valley - Twain
Las Vegas, Nevada, 89169
United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89218
United States
Gabrail Cancer and Research Center
Canton, Ohio, 44718
United States
The Toledo Clinic Cancer Center
Toledo, Ohio, 43623
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Taiho Oncology, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-30
Study Completion Date2026-08-24

Study Record Updates

Study Start Date2023-06-30
Study Completion Date2026-08-24

Terms related to this study

Keywords Provided by Researchers

  • Exon 20 insertion mutation
  • NSCLC
  • phase 3
  • Lung disease
  • Carcinoma, Non-Small-Cell Lung
  • CLN-081
  • TAS6417
  • EGFR

Additional Relevant MeSH Terms

  • Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation