NSCLC with uncommon EGFR mutations, including exon 20 insertion mutations
Conditions
Interventions
Arm A: 4 cycles of platinum-based chemotherapy (cisplatin or carboplatin plus pemetrexed) in combination with zipalertinib 100 mg BID followed by zipalertinib 100 mg BID alone for a total of 3 years.
Sponsors
Calleja Elizabeth
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent 2. >=18 years of age (or meets the country's regulatory definition for legal adult age, whichever is greater) 3. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology 4. Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendments (CLIA) certified (US) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt: a. exon20 insertion mutations or b. other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I) 5. MRI or CT scan of the brain done prior to surgery. Participants in whom this was not done prior to surgery may still be enrolled if appropriate imaging (ie, MRI or CT of the brain) is performed prior to randomization. 6. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumor. Resection may be accomplished by open thoracotomy or Video Associated Thoracic Surgery (VATS) techniques. 7. Classified post-operatively as either Stage IB, IIA, IIB, or IIIA according to the TNM staging system for lung cancer (AJCC 9th edition). 8. Complete recovery from surgery at the time of randomization.
Exclusion criteria
Exclusion criteria: 1. Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. 2. Treatment with any of the following within the time frame specified: a. Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time b. Pre-operative or post-operative or planned radiation therapy for the current lung cancer c. Any prior systemic anticancer therapy (eg, neoadjuvant chemotherapy), including investigational therapy, for treatment of NSCLC d. Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study treatment e. All prescribed medication, over-the-counter medication, vitamin preparations and other food supplements, or herbal medications that are strong or moderate cytochrome p450 (CYP) 3A4 inducers or inhibitors within 7 days prior to first dose f. Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known 3. Has received only segmentectomies or wedge resections 4. Past medical history of ILD/pneumonitis, drug-induced ILD/pneumonitis or any evidence of clinically active ILD/pneumonitis. 5. Impaired cardiac function or clinically significant cardiac diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) by investigator assessment | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Greece, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, Singapore, South Korea, Spain, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactTakayuki Yonehara
Taiho Pharmaceutical Co., Ltd.
Outcome results
None listed