A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer

Inclusion Criteria

• •1. Male or female patients ≥20 years old.
• •2. Must have measurable disease by RECIST v1.1. Previously irradiated lesions may not be used for target lesions, unless there is unambiguous radiological progression after radiotherapy.
• •3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• •4. Minimum life expectancy of 3 months or more.
• •5. Adequate renal and hepatic function as defined by the following criteria:
• ••Total serum bilirubin ≤1.5 × upper limit of normal (ULN) (≤3.0 × ULN for patients with Gilbert syndrome or if liver function abnormalities are due to underlying malignancy);
• ••Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (or ≤5 × ULN if liver function abnormalities are due to underlying malignancy);
• ••Estimated creatinine clearance ≥30 mL/min (calculated by using the Cockcroft-Gault equation);
• ••Serum albumin ≥2 g/dL; and
• ••Serum lipase ≤1.5 × ULN; and
• ••Serum amylase ≤1.5 × ULN unless the increased serum amylase is due to salivary isoenzymes.
• •6. Adequate bone marrow function as defined by the following criteria:
• •* Absolute neutrophil count ≥1.5 × 109/L;
• •* Platelet count ≥75 × 109/L in Phase 1 Part and ≥100 × 109/L in Phase 2 Part; and
• •* Hemoglobin ≥9.0 g/dL.
• •7. Normal QT interval on screening ECG, defined as QTcF of ≤450 ms in males or ≤470 ms in females.
• •8. Female patients who:
• •* Are postmenopausal (natural amenorrhea and not due to other medical reasons) for at least 1 year before the screening visit, OR
• •* Are surgically sterile, OR
• •* If they are of childbearing potential, agree to practice 1 highly effective non-hormonal method of contraception and 1 additional effective (barrier) method (see Section 8.7.1) at the same time, from the time of signing the informed consent form (ICF) through 30 days after the last dose of study drug, OR
• •* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
• •Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.
• •Male patients, even if surgically sterilized (ie, status postvasectomy), who:
• •Agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, OR
• •Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
• •Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.
• •9.Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
• •10.Willingness and ability to comply with scheduled visits and study procedures.
• •1.Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) (Stage IIIB) or metastatic NSCLC (Stage IV).
• •2.Refractory to standard available therapies. 3.All toxicities from prior therapy have resolved to ≤ grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or have resolved to baseline, at the time of first dose of Mobocertinib. Note: treatment-related grade \>1 alopecia or treatment-related grade 2 peripheral neuropathy are allowed if deemed irreversible.
• •1. Histologically or cytologically confirmed locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC.
• •2. Not received prior systemic treatment for locally advanced or metastatic disease (with the exception below): Neoadjuvant or adjuvant chemotherapy/immunotherapy for Stage I to III or combined modality chemotherapy/radiation for locally advanced disease is allowed if completed \>6 months before the development of metastatic disease.
• •3. A documented EGFR in-frame exon 20 insertion (including A763\_Y764insFQEA, V769\_D770insASV, D770\_N771insNPG, D770\_N771insSVD, H773\_V774insNPH, or any other in-frame exon 20 insertion mutation) by a local test that has been analytically validated per local authority guidelines. The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations except EGFR common mutations (exon 19 del or L858R).
• •4. Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR in-frame exon 20 insertion mutation. Note: confirmation of central test positivity is not required before the first dose of Mobocertinib.
• •10.Have gastrointestinal illness or disorder that could affect oral absorption of Mobocertinib.
• •11.Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.