Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.

Inclusion criteria

• . Ability to understand and willingness to sign a written informed consent document.
• . Aged at least 18 years old.
• . Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
• . Tumor tissue is positive for EGFR Ex20ins as documentally confirmed by next-generation sequencing (NGS) testing or written confirmation of PCR testing by a local laboratory accredited by the Clinical Laboratory Improvement Act Amendments (CLIA), International Organization for Standardization/Independent Ethics Committee (ISO/IEC), American College of Pathologists (CAP), or a central laboratory designated by the sponsor by a tertiary A hospital or with Clinical Laboratory Improvement Act Amendments (CLIA), International Organization for Standardization/Independent Ethics Committee (ISO/IEC), American College of Pathologists (CAP) accreditation (or other equivalent accreditation).
• . At least one measurable lesion as defined by RECISTV1.1（Brain lesions were not included in measurable target lesions）
• . ECOG performance status 0 to 1.
• . Life expectancy is not less than 12 weeks.
• . No previous systemic treatment for locally advanced or metastatic non-squamous cell cancer NSCLC. Note: Subjects are allowed to receive neoadjuvant/adjuvant therapy as long as the relevant therapy has ended at least 6 months before the disease is diagnosed as locally progressive or metastatic tumors

Exclusion criteria