Looking for a potential treatment approach for advanced non-small cell lung cancer?
Consider REZILIENT (REsearching ZIpaLertinib In Egfr Non-small cell lung cancer Tumors) Studies of the investigational drug, zipalertinib
Find a study center near youThe REZILIENT studies are for adults who have non-small cell lung cancer (NSCLC) and certain genetic mutations called epidermal growth factor receptor (EGFR) mutations.
The REZILIENT2 and REZILIENT4 studies are testing an investigational drug called zipalertinib. In an ongoing study, the investigational drug has shown antitumor activity on EGFR NSCLC.
The REZILIENT2 Study will test the safety and effectiveness of zipalertinib in participants who have advanced or metastatic NSCLC and selected EGFR mutations.
The REZILIENT4 Study will test whether zipalertinib after surgery can prevent cancer from coming back in participants who already had complete surgical resection (removal) of their NSCLC tumor with uncommon EGFR mutations.
You may be eligible for the REZILIENT2 Study if you:
- Are 18 years of age or older
- Have been diagnosed with locally advanced or metastatic NSCLC
- Have a documented mutation in the EGFR exon 20 insertion mutation gene or other uncommon mutations
- Have not previously received zipalertinib
You may be eligible for the REZILIENT4 Study if you:
- Are 18 years of age or older
- Have been diagnosed with NSCLC
- Have documented EGFR exon 20 insertion mutation gene or other uncommon mutations
- Have had a complete surgical resection (removal) of your tumor
- Have not previously received zipalertinib
Other eligibility criteria will need to be met to confirm your eligibility for the REZILIENT studies.
The REZILIENT2 Study includes:
- Screening: up to 4 weeks
- Treatment Period: ongoing 21-day cycles
- Follow-up Period: 30 days after the end of the treatment period and then every 12 weeks
- All primary REZILIENT2 cohorts (A–D) are now closed to enrollment. However, 2 new REZILIENT2 substudies are currently open and enrolling eligible participants. These substudies are evaluating zipalertinib in additional research settings and may be an option for individuals who meet specific eligibility criteria:
- Dose Optimization Substudy: This substudy is evaluating 2 different starting doses of zipalertinib to better understand the balance of safety, tolerability, and potential benefit. Participants will be randomly assigned to 1 of 2 study doses and will receive continuous 21‑day treatment cycles as part of ongoing research to help determine an optimized dose.
- Drug–Drug Interaction (DDI) Substudy: This substudy is assessing how zipalertinib interacts with certain commonly used medications in the body. Participants receive small “probe doses” of these medications once before beginning zipalertinib and again after starting treatment so researchers can measure any changes in how the body processes these drugs.
- Dose Optimization Substudy: This substudy is evaluating 2 different starting doses of zipalertinib to better understand the balance of safety, tolerability, and potential benefit. Participants will be randomly assigned to 1 of 2 study doses and will receive continuous 21‑day treatment cycles as part of ongoing research to help determine an optimized dose.
Qualified participants in the REZILIENT Studies will receive all study-related visits, tests, and the investigational drug, as well as close care and monitoring from a dedicated medical team. The study does not cover routine medical care for your condition or the medications you are prescribed for your condition.
Participants who qualify to take part in the study may receive reimbursement for study-related expenses.
The REZILIENT4 Study includes:
- Screening: up to 4 weeks
- Treatment Period: up to 3 years
- Follow-up Period: 30 days after the end of the treatment period and then every 24 weeks for up to 5 years
After screening, eligible participants will be randomly assigned (like the flip of a coin) to receive either zipalertinib, or placebo, which looks like zipalertinib, but contains no active ingredients, for up to 3 years.
Participants in the REZILIENT studies will receive all study-specific visits, tests, and the investigational drug or placebo, as well as close care and monitoring from a dedicated medical team. The studies do not cover routine medical care for your condition or the medications you are prescribed for your condition.
Participants who qualify to take part in the studies may receive reimbursement for study-related expenses.
Find a study Center
Please select the study center that is most convenient for you.
Clinical research studies are needed to determine whether an investigational drug is safe and effective to treat a particular condition or group of patients.
During these studies, information is collected on the effects of the investigational drug being taken. Once a clinical research study is completed, regulatory agencies carefully review the information. They then decide whether the study drug should be investigated further.
There are guidelines and regulations that must be followed during clinical research studies to help protect the rights, safety and privacy of those patients taking part. The rules also make sure the studies are conducted ethically and within approved medical standards.
Frequently asked questions
The REZILIENT2 study is testing the safety and effectiveness of an investigational drug called zipalertinib in participants who have advanced or metastatic non-small cell lung cancer (NSCLC) and who have epidermal growth factor receptor (EGFR) mutations.
The REZILIENT4 study is testing the safety and effectiveness of the same investigational drug called zipalertinib in participants who underwent surgery to completely remove NSCLC with uncommon EGFR mutations.
Approximately 160 people are expected to take part in REZILIENT2 main study cohorts (which are now closed), while 124 participants are anticipated across the 2 REZILIENT2 substudies, and 360 participants for the REZILIENT4 Study.
There is no cost to participate in the REZILIENT studies. If you decide to take part, you will receive:
- Study-related care from a team of experienced doctors and nurses throughout the study
- All study-related visits, tests, and the investigational drug (if you are assigned to receive it)
To find a center participating in the REZILIENT studies, visit the “Find a Study Center” section of this website and enter your city or your ZIP code/postal. Once you find a study center you may call or email the study team at that center for more information about the study and to see if you may qualify.
You may also find information about participating study centers and contact information by visiting clinicaltrials.gov.
Click here for information on REZILIENT2 and here for REZILIENT4.
During a clinical study, you may receive the medication that is being studied. This will be done at scheduled times and may occur only once or multiple times throughout the study, depending on the medication. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication. All study volunteers are always closely monitored by clinic staff and the medical team to ensure their safety.
Participation in any clinical study is completely voluntary. Your decision to participate – or not participate – in these clinical studies will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in one of these studies, you may leave the clinical study at any time and for any reason.
You may receive reimbursement for study-related expenses. For more information, please speak with a member of the study team during your study visits.
There are many reasons to participate in clinical research. One of the reasons is that it allows participants to play a more proactive role in their own health by receiving a new treatment for an ongoing disease or condition. Participants also play an important part in bringing much-needed drugs to market, benefiting thousands of people who also have the disease or condition.
As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled. Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant.
Taiho Oncology Inc. is responsible for conducting these clinical studies.
