Non-Small Cell Lung CancerNCT07601399
An EAP Treatment Protocol of Zipalertinib
A study testing Zipalertinib in people with Non-Small Cell Lung Cancer, run by Taiho Oncology, Inc..
Trial summary
"Only licensed physicians may submit an email inquiry/question about Taiho's Zipalertinib Expanded Access Program via email (Zipalertinib@parexel.com). If you are a patient or caregiver, do not email Parexel or Taiho. Please talk to your physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Zipalertinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Has provided written informed consent.
- Has histologically confirmed, locally advanced, metastatic, or recurrent unresectable NSCLC with EGFR ex20ins mutations based on testing performed by a qualified (CLIA certified) laboratory.
- 4. Has measurable or nonmeasurable lesion(s). 5. Has progressed on or after platinum-based chemotherapy with or without amivantamab.
- 6. Has progressed on available standard therapy or is unable to tolerate such standard therapy.
- 7. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
- 8. Has adequate organ function. 9. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test prior to administration of the first dose of zipalertinib.
- 10. Both males and females of reproductive potential must agree to use effective birth control during the program prior to the first dose of zipalertinib and for 1 week after the last dose of zipalertinib.
- 11. Is able to take medications orally (feeding tube is not permitted).
Who cannot join
- Has a history and/or current evidence of any of the following:
- Past medical history of interstitial lung disease, treatment-related pneumonitis (any grade), or evidence of clinically active interstitial lung disease
- Impaired cardiac function or clinically significant cardiac disease including any of the following:
- History of congestive heart failure Class III/IV according to the New York Heart Association Functional Classification
- Serious cardiac arrhythmias requiring treatment
- Use of zipalertinib (TAS6417/CLN-081) at any time.
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- Has not recovered from side effects of the following prior therapies:
- Have any unresolved toxicity of Grade ≥ 2 from previous anticancer treatment, except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the treatment physician and Sponsor.
- Thoracic radiotherapy ≤ 28 days or palliative radiation (gamma knife radiotherapy is allowed) ≤ 14 days prior to the first dose of zipalertinib
- Anticancer immunotherapy ≤ 28 days prior to the first dose of zipalertinib
- Major surgery (excluding placement of vascular access) ≤ 28 days prior to the first dose of zipalertinib.
- Has a serious illness or medical condition(s) that in the judgment of the treating physician would make the patient inappropriate for entry into this program.
- Has a history of another primary malignancy whose natural history or treatment has the potential to interfere with the safety assessment of zipalertinib in the opinion of the treating physician.
- Has known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class.
- Is pregnant, lactating, or planning to become pregnant.
Trial locations and contacts
No sites are listed yet.
Taiho Oncology, Inc. (Sponsor) contact
About this study
Official title: An Open-Label Expanded Access Program of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations Whose Disease Has Progressed on or After Platinum-Based Chemotherapy With or Without Amivantamab
"Only licensed physicians may submit an email inquiry/question about Taiho's Zipalertinib Expanded Access Program via email (Zipalertinib@parexel.com). If you are a patient or caregiver, do not email Parexel or Taiho. Please talk to your physician. Do not share any patient Personally Identifiable Information with Parexel."
The objective of the study is to provide access to zipalertinib to patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy with or without amivantamab.
Read the detailed description
This is an open-label EAP treatment protocol of zipalertinib for the treatment of patients with advanced NSCLC with EGFR ex20ins mutations who have exhausted standard treatment options, are new to therapy with zipalertinib, and for whom therapy with zipalertinib is clinically indicated.
Patients will be enrolled through the MyAccess Programs Platform.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Zipalertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZipalertinibDrug
Participants will self-administer 100 mg dose, orally, twice daily (BID), continuously in 28-day cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601399
- Sponsor's protocol ID
- TAS6417-401
- Status last verified
- Jun 2026
- First submitted
- 13 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Expanded Access Program of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations Whose Disease Has Progressed on or After Platinum-Based Chemotherapy With or Without Amivantamab
- ClinicalTrials.gov ID
- NCT07601399
- Acronym / sponsor ID
- TAS6417-401
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Only licensed physicians may submit an email inquiry/question about Taiho's Zipalertinib Expanded Access Program via email (Zipalertinib@parexel.com). If you are a patient or caregiver, do not email Parexel or Taiho. Please talk to your physician. Do not share any patient Personally Identifiable Information with Parexel."
The objective of the study is to provide access to zipalertinib to patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy with or without amivantamab.
Detailed description
This is an open-label EAP treatment protocol of zipalertinib for the treatment of patients with advanced NSCLC with EGFR ex20ins mutations who have exhausted standard treatment options, are new to therapy with zipalertinib, and for whom therapy with zipalertinib is clinically indicated.
Patients will be enrolled through the MyAccess Programs Platform.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has provided written informed consent.
- Has histologically confirmed, locally advanced, metastatic, or recurrent unresectable NSCLC with EGFR ex20ins mutations based on testing performed by a qualified (CLIA certified) laboratory.
- 4. Has measurable or nonmeasurable lesion(s). 5. Has progressed on or after platinum-based chemotherapy with or without amivantamab.
- 6. Has progressed on available standard therapy or is unable to tolerate such standard therapy.
- 7. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
Key exclusion criteria (15 listed)
- Has a history and/or current evidence of any of the following:
- Has not recovered from side effects of the following prior therapies:
- Has a serious illness or medical condition(s) that in the judgment of the treating physician would make the patient inappropriate for entry into this program.
- Has a history of another primary malignancy whose natural history or treatment has the potential to interfere with the safety assessment of zipalertinib in the opinion of the treating physician.
- Has known hypersensitivity to the ingredients in zipalertinib or any drugs similar in structure or class.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZipalertinibParticipants will self-administer 100 mg dose, orally, twice daily (BID), continuously in 28-day cycles. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taiho Oncology, Inc. (Sponsor) contact
Questions about this trial
What is this clinical trial studying?
A study testing Zipalertinib in people with Non-Small Cell Lung Cancer, run by Taiho Oncology, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taiho Oncology, Inc. (Sponsor) (Zipalertinib@parexel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.