An EAP Treatment Protocol of Zipalertinib

NCT07601399 | Unknown

• 1 other identifier: TAS6417-401
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Interventions

Zipalertinib DRUG

Participants will self-administer 100 mg dose, orally, twice daily (BID), continuously in 28-day cycles.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Has measurable or nonmeasurable lesion(s). 5. Has progressed on or after platinum-based chemotherapy with or without amivantamab.
• \. Has progressed on available standard therapy or is unable to tolerate such standard therapy.
• \. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• \. 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.
• \. 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.
• \. Is able to take medications orally (feeding tube is not permitted).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

zipalertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Taiho Oncology, Inc. (Sponsor)

CONTACT

Zipalertinib@parexel.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 22, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05