Tagrisso (osimertinib)

P1/2, N=200, Recruiting, Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Trial completion date: Dec 2029 --> Dec 2028 | Trial primary completion date: Dec 2028 --> Jun 2028

Specifically, the mean OS was longer for patients with higher VAF in both the overall cohort and in subgroups with EGFR exon 19 deletions and exon 21 L858R mutations. These findings suggest that VAF could serve as a valuable predictive biomarker for treatment outcomes in EGFR-mutated NSCLC patients, highlighting its potential role in personalizing treatment strategies.

P1, N=403, Recruiting, AstraZeneca | Trial completion date: Oct 2027 --> Aug 2028 | Trial primary completion date: Oct 2027 --> Aug 2028

1 Article types. Original Research.

OB-001, a KinetiSol® amorphous solid dispersion formulation of elacridar, was developed to overcome poor bioavailability of crystalline elacridar and evaluated as a strategy to enhance osimertinib brain delivery. OB-001 selectively boosts osimertinib brain exposure while sparing systemic PK. These preclinical data support further evaluation of OB-001 as a strategy to enhance CNS efficacy of osimertinib in EGFR-mutant NSCLC.

First-line osimertinib provides prolonged OS and meaningful economic benefits over second-generation TKIs. Given the higher toxicity burden of sequential therapy despite similar survival outcomes, our findings support the implementation of first-line osimertinib to optimize patient experience and reduce health care utilization in metastatic EGFR-mutant NSCLC.

P3, N=582, Recruiting, AstraZeneca | Trial completion date: May 2032 --> Aug 2031

We present a case of a 66-year-old female with de novo metastatic NSCLC harboring an EGFR mutation, RET rearrangement, and ERBB2 amplification, who experienced transformation to SCLC while on osimertinib. Subsequently, she exhibited primary refractory disease to both first-line platinum doublet with immunotherapy and second-line lurbinectedin...The patient had minimal side effects and obtained a partial response with a progression-free survival (PFS) of 13.1 months, better than historically poor prognosis seen in transformed SCLC. This case underscores the potential role of human epidermal growth factor receptor 2 (HER-2) directed therapies, such as T-DXd, in transformed SCLC.

To our knowledge, this is the first report to demonstrate the efficacy of carboplatin, pemetrexed, and amivantamab against LMD progression after osimertinib therapy, suggesting that this regimen may be a therapeutic option for patients with LMD, including those with symptomatic disease. Nevertheless, further studies are warranted to confirm efficacy in this population.

This study identifies/validates key mechanisms of EGFR-TKI resistance and suggests combinatorial therapeutic strategies as potential interventions against EGFR-TKI-resistant lung cancers, with promising implications for improving clinical outcomes.

P3, N=216, Active, not recruiting, AstraZeneca | Trial completion date: Apr 2027 --> Oct 2027