Endpoints and assessments
NSCLC, tumor, Tumor, allergy, Cancer
ADVERSE EVENT, TUMOR, METASTASIS, TUMOR, ADVERSE EVENT, ALLERGY, BRAIN, NSCLC, DISEASE, CANCER
The primary objective was to evaluate safety and tolerability of JMT101 plus afatinib or osimertinib in advanced or metastatic NSCLC harboring EGFR 20ins. Secondary objectives included anti-tumor activity measured by tumor responses (ORR, DCR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS), pharmacokinetics, immunogenicity, and biomarkers potentially associated with clinical outcomes.Adverse events were monitored throughout the study until 30 days after the last dose, and were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Disease assessment by radiologic imaging was conducted at screening, 4 weeks of study treatment and every 8 weeks thereafter. At screening, contract-enhanced CT scans of the chest, full abdomen and pelvis, contrast-enhanced brain MRI and a bone scan (ECT) are required for all participants (in case of allergy to the contrast medium or contraindication, plain CT scan or MRI scan is acceptable). For patients without baseline CNS metastasis, the following tumor assessment will include CT scans of the chest, full abdomen and/or pelvis. Brain MRI will only be performed when clinical indicated. For patients with baseline CNS metastasis, the following assessment will include CT scans as mentioned above and a brain MRI. Tumor response was determined by a central independent review committee (IRC) and investigators per RECIST v1.1