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
The REZILIENT studies are for adults who have advanced or metastatic non-small cell lung cancer (NSCLC) and certain genetic mutations called epidermal growth factor receptor (EGFR) mutations.
The REZILIENT2 and REZILIENT3 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 REZILIENT3 Study will test the safety and effectiveness of zipalertinib in combination with standard chemotherapy for those with previously untreated advanced or metastatic nonsquamous NSCLC and selected 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 REZILIENT3 Study if you:
- Are 18 years of age or older
- Have been diagnosed with locally advanced or metastatic non-squamous NSCLC
- Have not received any prior systemic treatment for your advanced NSCLC and, if applicable, last received treatment for early-stage NSCLC more than six months ago
- Have a documented mutation in the EGFR exon 20 insertion mutation gene
- 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
After screening to determine eligibility for the study, participants will enter the treatment period, during which zipalertinib will be tested in the following groups (or cohorts) of participants:
- Cohort A: Those whose cancer has progressed on or after systemic therapy with an agent targeting exon 20 insertion mutations, either alone or in combination with standard platinum-based chemotherapy
- Cohort B: Those who have exon 20 insertion mutation and have not received prior treatment for their advanced disease
- Cohort C: Those who have exon 20 insertion mutations or other uncommon mutations and active brain metastases
- Cohort D: Those who have other non-exon 20 insertion uncommon single or compound EGFR mutation status
Qualified participants in both 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 that you are prescribed for your condition.
Participants who qualify to take part in the study may receive reimbursement for study-related expenses.
The REZILIENT3 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 for up to 3 years
After screening to determine eligibility for the study, participants will enter the treatment period. Depending on when they begin in the study, some participants may participate in the first part of the study to confirm the recommended dose of zipalertinib. During the second part of the study, all participants will be randomly assigned (like tossing a coin) to receive either zipalertinib (which comes in tablet/capsule form) with standard chemotherapy or receive standard chemotherapy alone.
Participants in both REZILIENT Studies will receive all study-related visits, tests, and the investigational drug (if assigned to receive it), 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 that you are prescribed for your condition.
Participants who qualify to take part in the study may receive reimbursement for study-related expenses.
Clinical research studies are needed to establish 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 to protect the rights, safety and privacy of those patients taking part. The rules also make sure that the studies are conducted ethically and within approved medical standards.
Frequently asked questions
The REZILIENT Studies are 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.
Approximately 160 people are expected to take part in REZILIENT2 and 300 people in REZILIENT3.
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 centre participating in the REZILIENT Studies, visit the "Find a Study Centre" section of this website and enter your city or your post code. Once you find a study centre you may call or email the study team at that centre for more information about the study and to see if you may qualify.
You may also find information about participating study centres and contact information by visiting ClinicalTrials.gov. Click here for information on REZILIENT2 and here for REZILIENT3.
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 examinations 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, benefitting 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 that 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.
