Efficacy and safety of SMET12 in combination with toripalimab and chemotherapy in advanced non-small-cell lung cancer patients tested positive for EGFR protein who are treatment-naïve or harbor acquired resistance to standard therapy: a phase 2, multi-cohort clinical trial
Abstract
Objective SMET12 is a bispecific T-cell engager targeting epidermal growth factor receptor (EGFR) and CD3. This phase 2 clinical trial aimed to investigate the efficacy and safety of SMET12 plus toripalimab and chemotherapy among advanced non-small-cell lung cancer (NSCLC) patients tested positive for EGFR protein, including treatment-naïve patients, patients with resistance to first-line immune checkpoint inhibitors-containing therapy and EGFR-mutated patients with resistance to first-line EGFR tyrosine kinase inhibitors (TKIs), and to examine the associations of lymphocyte numbers and differentiation patterns with therapeutic efficacy among advanced NSCLC patients. Methods All advanced NSCLC patients were histologically diagnosed and tested positive for EGFR protein. This trial included three cohorts: Cohort A consisted of treatment-naïve patients, and Cohort B consisted of patients acquiring resistance to first-line immune checkpoint inhibitors-containing therapy, while Cohort C consisted of EGFR-mutated patients acquiring resistance to TKIs. All participants received triple therapy with SMET12, toripalimab and chemotherapy, and participants with complete response (CR), partial response (PR) or stable disease (SD) following 2 to 4 cycles of chemotherapy were given maintenance therapy with SMET12 plus toripalimab until progressive disease (PD) or unacceptable toxicity. Primary endpoints included safety and efficacy measures, including objective response rate (ORR), disease…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 32 participants or records.
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