REZILIENT4
Research type
Research Study
Full title
A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients with Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)
IRAS ID
1012763
Contact name
Kazu Kato
Contact email
Sponsor organisation
Taiho Oncology, Inc
Clinicaltrials.gov Identifier
Research summary
Researchers are looking for different ways to treat people with non-small cell lung cancer (NSCLC).
The study drug, zipalertinib, is being developed to help people with NSCLC who have uncommon EGFR gene mutations. It blocks the signals from the EGFR gene that causes cancer cells to grow. This study will check if adding zipalertinib to approved cancer drugs given after surgery can help stop cancer from coming back.
There are many types of clinical studies. This study will be:
• Phase 3: In a Phase 3 study, a treatment is tested in a large number of participants. It is usually the last phase of a clinical program before a treatment is submitted to the health or government authority for approval.
• Randomized: Researchers will use a computer program to randomly assign each participant either zipalertinib or placebo, along with other cancer drugs. This helps to make sure the study treatments are chosen fairly.
• Double-blind: Researchers and participants will not know which study drug they will receive.About 360 people who are at least 18 years old can enroll in this study. They must have NSCLC with uncommon EGFR gene mutations and meet the study requirements
The study will have up to 4 periods; Screening, Treatment, Safety Follow up and Long Term Follow up.
All participants will receive either 100 milligrams of zipalertinib or placebo, orally as tablets, along with other cancer drugs, twice a day in a 21-day cycle. These drugs will be given as an injection into a vein, also called an intravenous (IV) infusion. Participants will receive this combination treatment for up to 4 cycles. After that, they will continue receiving zipalertinib or placebo for up to a total of 3 years.
In addition to physical exams and vital sign measurements, participants may have the following tests and procedures:
Body imaging scans, blood and urine tests, diary completion, heart tests, questionnaires, eye examination.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0188
Date of REC Opinion
13 Nov 2025
REC opinion
Further Information Favourable Opinion