Deulorlatinib (TGRX-326) in ALK gene fusion positive non-small cell lung cancer after failure of second-generation inhibitors (DRAGON): a single-arm, multicenter, phase 2 trial.
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Lung Cancer Treatments and Mutations
Lung Cancer Research Studies
Lung Cancer Diagnosis and Treatment
[INTRODUCTION] Deulorlatinib (TGRX-326), a potent third-generation anaplastic lymphoma kinase (ALK) inhibitor, has shown promising activity and a favorable safety profile in ALK-positive non-small cel
- 표본수 (n) 43
- 95% CI 35.8-51.8
APA
Jie Huang, Gang Chen, et al. (2026). Deulorlatinib (TGRX-326) in ALK gene fusion positive non-small cell lung cancer after failure of second-generation inhibitors (DRAGON): a single-arm, multicenter, phase 2 trial.. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 103737. https://doi.org/10.1016/j.jtho.2026.103737
MLA
Jie Huang, et al.. "Deulorlatinib (TGRX-326) in ALK gene fusion positive non-small cell lung cancer after failure of second-generation inhibitors (DRAGON): a single-arm, multicenter, phase 2 trial.." Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2026, pp. 103737.
PMID
42031067
Abstract
[INTRODUCTION] Deulorlatinib (TGRX-326), a potent third-generation anaplastic lymphoma kinase (ALK) inhibitor, has shown promising activity and a favorable safety profile in ALK-positive non-small cell lung cancer (NSCLC) in a phase 1 trial. Here, we report the primary results of the pivotal phase 2 trial (NCT05955391) evaluating deulorlatinib in patients with ALK-positive NSCLC who had failed second-generation ALK inhibitors.
[METHODS] This single-arm, phase 2 trial was conducted at 36 centers in China. Eligible patients received deulorlatinib 60 mg once daily. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC). Key secondary endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response (DoR), overall survival (OS), intracranial efficacy, and safety. Exploratory biomarker analyses were performed using cell-free DNA.
[RESULTS] The efficacy and safety analysis sets comprised 158 and 163 patients, respectively. The primary endpoint was met with an IRC-assessed ORR of 43.7% (95% CI, 35.8-51.8). The IRC-assessed median PFS was 11.1 months (95% CI, 8.3-13.7). Among patients with measurable central nervous system (CNS) metastases (N = 43), the intracranial ORR was 55.8% (95% CI, 39.9-70.9). In patients harboring the G1202R mutation (N = 8), robust activity was observed (ORR: 62.5%; DCR: 100%; median PFS: 11.0 months). The investigator-assessed results were consistent with the IRC-assessed findings. Treatment-related adverse events (TRAEs) occurred in 96.3% of patients (47.2% grade ≥ 3). However, dose modifications were infrequent (interruption, 13.5%; reduction, 11.0%; permanent discontinuation, 0.6%). The incidence of CNS-related TRAEs was 12.9%, with no patients interrupting or discontinuing treatment due to CNS toxicity.
[CONCLUSIONS] Deulorlatinib demonstrated encouraging anti-tumor activity in patients with advanced ALK-positive NSCLC after failure of second-generation ALK inhibitors, including those with the G1202R mutation. Given its favorable safety profile, deulorlatinib represents a promising new option for this population.
[METHODS] This single-arm, phase 2 trial was conducted at 36 centers in China. Eligible patients received deulorlatinib 60 mg once daily. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC). Key secondary endpoints included disease control rate (DCR), progression-free survival (PFS), duration of response (DoR), overall survival (OS), intracranial efficacy, and safety. Exploratory biomarker analyses were performed using cell-free DNA.
[RESULTS] The efficacy and safety analysis sets comprised 158 and 163 patients, respectively. The primary endpoint was met with an IRC-assessed ORR of 43.7% (95% CI, 35.8-51.8). The IRC-assessed median PFS was 11.1 months (95% CI, 8.3-13.7). Among patients with measurable central nervous system (CNS) metastases (N = 43), the intracranial ORR was 55.8% (95% CI, 39.9-70.9). In patients harboring the G1202R mutation (N = 8), robust activity was observed (ORR: 62.5%; DCR: 100%; median PFS: 11.0 months). The investigator-assessed results were consistent with the IRC-assessed findings. Treatment-related adverse events (TRAEs) occurred in 96.3% of patients (47.2% grade ≥ 3). However, dose modifications were infrequent (interruption, 13.5%; reduction, 11.0%; permanent discontinuation, 0.6%). The incidence of CNS-related TRAEs was 12.9%, with no patients interrupting or discontinuing treatment due to CNS toxicity.
[CONCLUSIONS] Deulorlatinib demonstrated encouraging anti-tumor activity in patients with advanced ALK-positive NSCLC after failure of second-generation ALK inhibitors, including those with the G1202R mutation. Given its favorable safety profile, deulorlatinib represents a promising new option for this population.
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