EGFR exon 19 deletion

P2, N=300, Recruiting, Janssen Research & Development, LLC | N=180 --> 300

P2, N=74, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

P2, N=63, Active, not recruiting, Zhejiang Cancer Hospital | Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2024 --> Jun 2024

P2, N=100, Recruiting, The University of Sydney | Not yet recruiting --> Recruiting

NSCLC w/EGFRex19del & MET amp: durable intracranial + systemic response to amivantamab/osimertinib.

The OS and CNS-PFS of patients who received upfront LT for BMs followed by osimertinib were significantly longer than those of patients who received osimertinib alone. Upfront LT for BMs may be beneficial in patients with EGFR-mutant NSCLC treated with osimertinib.

P2, N=117, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2024 --> Sep 2024

Our findings provide evidences for tenovin-3 to be developed into a novel candidate agent for NSCLC with EGFR exon 19 deletion. Our study also suggests that inducing ferroptosis may be a therapeutic strategy for NSCLC with EGFR exon 19 deletion.

P2, N=125, Active, not recruiting, National Cancer Institute (NCI)

P2, N=277, Active, not recruiting, Daiichi Sankyo | N=420 --> 277

Patients in their 70s and 80s with non-small cell lung cancer were relatively frequently EGFR gene-positive. To avoid missing out on treatment opportunities, EGFR gene testing should also be performed on patients in this age group.

The radiomics model based on MRI of lung adenocarcinoma brain metastases could distinguish between EGFR 19Del and 21L858R mutations in the primary lesion.

P1/2, N=80, Recruiting, Janssen Research & Development, LLC | Trial completion date: Nov 2025 --> Aug 2026

P1, N=751, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2024 --> Jun 2025

TSO500 and F1CDx showed robust analytical performance for TMB assessment with TSO500 showing stronger concordance of TMB with high PD-L1 expression. As the paradigm for the management of early-resected NSCLC continues to evolve, understanding TMB and the mutation landscape may help advance clinical outcomes for this subset of patients.

In summary, ramucirumab may have similar effectiveness as bevacizumab in combination with an EGFR-TKI as first line therapy for advanced lung adenocarcinoma harboring susceptible EGFR mutation. Further large-scale registry-based cohort studies may be needed to validate our findings.

Moreover, the digital stepwise melting analysis (dSMA) technique is introduced, enabling high-multiplex profiling of seven major EGFR variants spanning 35 subtypes. This innovative dPCR system presents a cost-effective and versatile alternative, overcoming existing limitations and paving the way for transformative advances in precision diagnostics.

This specific mutation in exon 18 seems to respond to certain EGFR TKIs such as afatinib. However, given the rarity of this mutation, determining the most effective TKI for its treatment remains unclear. We report a 70-year-old woman diagnosed with stage IV-A lung adenocarcinoma harboring EGFR delE709_T710insD mutation treated in first-line with Osimertinib using standard schedule and doses experiencing renal toxicity and disease progression after 9 weeks of treatment.

P4, N=200, Recruiting, AstraZeneca | Trial completion date: Mar 2024 --> Jun 2024

Median overall survival (95% CI) was 21.30 (15.86-26.75) months. Lower afatinib doses (<40 mg OD) could be equally effective as standard dose in patients with EGFR-mutant advanced NSCLC and may be more suited to Asian patients, minimizing side effects that may occur at higher dosages of afatinib leading to dose interruptions and affecting treatment outcomes.

P3, N=545, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2023 --> Dec 2024

The EGFR exon 19 deletion mutation was more common in both MIA (50%; n = 6/12) and ADC (41%; n = 149/363), whereas p.L858R was more prevalent in AIS (75%; n = 3/4). In contrast to pulmonary advanced ADC, KRAS driver mutations are less common, whereas mutations in EGFR are more common, in detectable AIS and MIA.

P1, N=53, Active, not recruiting, Takeda | Trial completion date: Mar 2024 --> Mar 2025

In both the primary stage II-IIIA and overall stage IB-IIIA populations, patients in the osimertinib group had a significant 51% reduction in the risk of death compared with the placebo group. The data demonstrated that osimertinib after surgery significantly improved overall survival in patients with resected, EGFR-mutated, stage IB-IIIA NSCLC.

Cardiac MRI revealed significant left ventricular enlargement, lateral wall myocardial thinning, and localized myocardial fibrosis without perfusion defects, a finding not previously reported in literature. This case underscores the severe and unusual cardiac effects of osimertinib in patients with latent risk factors, highlighting the importance of vigilant cardiac monitoring and a multidisciplinary management approach.

One-stage surgery involving combined resection of lung cancer and the thoracic aortic wall with simultaneous thoracic aortic endografting in the right lateral decubitus position with the left inguinal region exposed is safe and acceptable.

Confirmation of EGFR mutation is important step in the diagnosis and selection of optimal drug for cancer patients. However, tissue biopsy has several limitations such as difficulties to get tissue samples and inaccurate information due to invasive method and tumor heterogeneity. Detection of EGFR mutation in CTC might overcome and make up for limitations of tissue biopsy.

We also present a case demonstrating a favorable response to the dual therapy of olaparib and osimertinib in NSCLC harboring EGFR, RAD50, and ARID1A mutations that progressed on osimertinib. There were 2298 patients in the NSCLC cohort (MSKCC database). HRD aberrations are uncommon in EGFR mutated lung cancer patients. Further investigation on the role of PARP inhibitor in EGFR mutated lung cancer is warranted.

In addition, this sensor was applied to the detection of ctDNA in serum samples and cells lysates. This method for ctDNA detection was expected to have great potential for biomarker detection in the field of liquid biopsy.

P1, N=344, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2023 --> Dec 2024

This analysis demonstrated long-term clinical benefit with lazertinib 240 mg in patients with EGFR-mutated NSCLC who had not previously received EGFR TKIs. The safety profile for lazertinib was tolerable and consistent with that previously reported.

P2, N=67, Recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2025 --> Aug 2026

MET positive expression was an independent predictor of poor outcomes in untreated EGFR L858R mutation advanced LUAD patients treated with first-line EGFR-TKI monotherapy.

P2, N=180, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting

Among NSCLC-LM patients with EGFR mutation, receiving EGFR-TKI combined with antiangiogenic therapy may result in a better survival benefit. The factors of primary LM, combined brain metastasis may be prognostic factors for poor OS.

P2, N=150, Active, not recruiting, Nantes University Hospital | Recruiting --> Active, not recruiting | N=66 --> 150 | Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Apr 2024 --> Jan 2025

TP53/EGFR co-mutation patients receiving first-line EGFR-TKI treatment had poor prognoses in advanced LUAD, especially with L858R mutation. Moreover, TP53/EGFR co-mutation patients treated with EGFR-TKIs may more easy developed intracranial metastasis.

HRQoL was maintained from baseline, and safety was consistent with the global population. In this population of Chinese patients from ADAURA, adjuvant osimertinib was found to have a clinically meaningful improvement in DFS versus placebo, with maintained HRQoL and a safety profile consistent with the global study population.

P2, N=32, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: May 2025 --> Jul 2026 | Initiation date: Dec 2023 --> Jun 2024 | Trial primary completion date: May 2025 --> Jul 2026

In this study, we demonstrated that BRAF status may not be capable of predicting prognosis in stage I LUAD patients. There is a need for more data to validate our findings.

In addition, the probability of disease progression over time was higher for L858R compared with that for exon 19 deletion mutation, in patients with central nervous system metastasis (log-rank test, p = 0.027). The mutation subtype had an impact not only on the clinical outcome of the first-line OSI treatment but also on progression patterns after OSI treatment in patients with NSCLC harboring EGFR mutations.

P2, N=118, Active, not recruiting, National Cancer Centre, Singapore | Trial completion date: Nov 2025 --> Mar 2026 | Trial primary completion date: Nov 2023 --> Mar 2026