Trial reportFrontiers in immunology2025
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.
Trial report in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06208033 (A Single-arm, Sequential Study Assessing the Efficacy and Safety of SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Single-arm, Sequential Study Assessing the Efficacy and Safety of SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC) : First-line Treatment or Failed From First-line Immune Checkpoint Inhibitor Treatment.
Who cites it
1 citing paper in PubMed.
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
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 Results: A total of 32 patients were included in the trial until January 21, 2025. The ORR, DCR and median PFS were 83.3%, 100% and 8.3 (95% Conclusions: Triple therapy consisting of SMET12, toripalimab, and chemotherapy exhibited manageable safety in patients with advanced non-small cell lung cancer (NSCLC) expressing EGFR protein, while demonstrating promising efficacy in EGFR-mutant patients with acquired resistance to EGFR-TKIs. The functional phenotype and differentiation pattern of peripheral blood T lymphocytes exert a critical impact on the therapeutic response to this triple therapy. Clinical trial registration: https://www.clinicaltrials.gov/study/, identifier NCT06208033.
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