JIN-A02 Plus Amivantamab in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Failure

Inclusion criteria

• Subjects aged 19 years or older.
• Subjects with advanced and/or metastatic NSCLC harboring an activating EGFR mutation (Ex19del or L858R), as confirmed by testing of tissue or blood samples, whose disease has progressed following treatment with a third-generation EGFR-TKI, such as osimertinib or lazertinib. Subjects who received platinum-based chemotherapy after EGFR-TKI treatment may have received no more than one such regimen.
• Subjects with at least one measurable lesion according to RECIST v1.1.
• Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion criteria

• Subjects with NSCLC histologically diagnosed as having a mixed squamous cell component or with histologic transformation, including transformation from NSCLC to small cell lung cancer (SCLC) or the presence of epithelial-to-mesenchymal transition.
• Subjects with uncontrolled symptomatic spinal cord compression or central nervous system (CNS) metastases; subjects requiring an increase in corticosteroid dose within 28 days before study initiation for the treatment of CNS disease; subjects requiring local treatment for CNS disease; or subjects with leptomeningeal disease. However, subjects whose condition remains stable or who are systemically asymptomatic at least 2 weeks after gamma knife treatment or at least 4 weeks after whole-brain irradiation may be eligible to participate in the study.
• Subjects who have received any of the following treatments:

• EGFR-TKI therapy or systemic anticancer therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of the investigational product, or any prior treatment with a fourth-generation EGFR-TKI.
• Limited-field radiotherapy within 7 days or extended-field thoracic radiotherapy within 14 days before the first dose of the investigational product.
• Immunotherapy or other antibody-based therapy within 28 days before the first dose of the investigational product.
• Major surgery, other than procedures such as central venous catheter placement, within 28 days before the first dose of the investigational product, or subjects who, in the investigator's judgment, have not recovered from surgery-related adverse effects.

*Major surgery is defined as surgery involving the abdominal, pelvic, cranial, thoracic, or localized tissues that, considering the surgical site, the subject's condition, the complexity of the procedure, or the duration of surgery, may pose a risk to organ or tissue function or to resuscitation. Major surgery generally requires general anesthesia, hospitalization of varying duration, often approximately 1 week, and may be performed by a surgical specialist.

• Subjects with toxicities related to prior anticancer therapy or radiotherapy that have not recovered to CTCAE Grade ≤1 or baseline. Exceptions may be made for toxicities considered clinically acceptable by the investigator, such as alopecia or stable peripheral neuropathy.
• Subjects who have previously received amivantamab.