EGFR exon 19 deletion

P3, N=630, Not yet recruiting, Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

P2, N=5, Not yet recruiting, Second Xiangya Hospital of CSU; Second Xiangya Hospital of CSU

P=N/A, N=150, Not yet recruiting, Shanghai East Hospital; Shanghai East Hospital

P1, N=176, Not yet recruiting, Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

RNA-sequencing based analysis revealed increased infiltration of CD8 + T-cells in post-treatment tumors compared to baseline, particularly in responsive and Ex19-Del mutation tumors. Collectively, neoadjuvant Aumolertinib showed promising efficacy and a surgical conversion rate with a tolerable safety profile for unresecable NSCLCm in stage III, potentially involved in the remodeling of tumor microenvironment.

The intercalation of cisplatin plus pemetrexed after the response to EGFR-TKI improved PFS but not OS compared with EGFR-TKI monotherapy as the first-line treatment for advanced NSqNSCLC harboring EGFR mutation.

Known resistance mechanisms were observed on ctDNA analysis at progression. These observations demonstrate the benefit of osimertinib for treating EGFR-mutated PDAC and highlight the interest in investigating rare molecular alterations, especially in patients without KRAS alterations.

P3, N=590, Active, not recruiting, Daiichi Sankyo | Trial completion date: Jun 2025 --> Jan 2026

These findings highlight LCCP's potential to improve personalized treatment strategies for NSCLC.

No abstract available

P2, N=300, Recruiting, Janssen Research & Development, LLC | N=200 --> 300

Furthermore, Piperlongumine significantly inhibited tumor growth in both Osimertinib-sensitive and resistant NSCLC xenograft models. These findings highlight the potential of Piperlongumine as an effective agent in overcoming EGFR-targeted therapy resistance and suggest new avenues for its clinical application in NSCLC treatment.

This is the first reported case highlighting the efficacy of a third-generation TKI in treating lung adenocarcinoma with this rare compound mutation. Our findings suggest that third-generation TKIs may be a viable therapeutic option for prolonging progression-free survival in this patient subset.

Retreatment with furmonertinib under prednisone could be considered as an effective therapeutic option after risk-benefit assessment for EGFR-mutant lung adenocarcinoma patients.

Next generation sequencing (NGS) identified an EGFR Ex19del mutation, which suggested the use of afatinib, as it was prescribed prior to osimertinib and was covered by insurance...Moreover, ALK and ROS1 were identified through immunohistochemistry (IHC), with ROS1 expression subsequently confirmed by fluorescence in situ hybridization (FISH); this prompted a switch to crizotinib, which was discontinued owing to further disease progression...A subsequent biopsy indicated a transformation to large cell neuroendocrine carcinoma, which led to treatment with platinum-etoposide chemotherapy and, later, paclitaxel and osimertinib, both of which are partially effective. Finally, a new biopsy confirmed ALK positivity in a large cell neuroendocrine carcinoma that was still harbouring an EGFR exon 19 deletion, so alectinib was introduced...These findings underscore the necessity of monitoring patients with oncogenic addiction through both liquid biopsy for on-target mechanism detection and tissue sampling to detect histological transformations. These mechanisms can occasionally be combined, thereby providing comprehensive panels at each stage of tumour progression.

This approach represents a promising alternative to tissue biopsy for molecular profiling, potentially expediting treatment decisions. While serum ddPCR showed limited utility, it may complement tissue genotyping in specific clinical scenarios.

Subgroup analyses also showed similar tendency that 21 L858R had more clinical benefit compared to 19 Del no matter whether IO monotherapy or IO combination. For advanced EGFR mutant NSCLC patients, 21 L858R had superior IO efficacy compared with 19 Del.

P2, N=117, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2025 --> Sep 2025 | Trial primary completion date: Jun 2025 --> Sep 2025

In line with data already available from previously published studies, EGFR mutation is also a common finding in patients with lung adenocarcinoma, especially among women, and the exon 19 deletion is the most common variation. Incorporating EGFR mutation testing into early diagnostic protocols remains crucial for optimizing treatment strategies and improving patient outcomes.

P3, N=354, Active, not recruiting, Takeda | Trial completion date: Jul 2025 --> Sep 2026 | Trial primary completion date: Dec 2024 --> Sep 2026

Aumolertinib plus chemotherapy shows potential as first-line treatment for patients with EGFR-mutant advanced NSCLC, which deserves to be investigated in randomized controlled trials. CtDNA clearance may be a prognostic marker.

Our preclinical, structural, and clinical findings indicate 2nd-generation EGFR-TKIs are more effective for EGFRex19ins compared to other TKIs.

Our findings improve the understanding of lung cancer genetics in a small and homogeneous area of Southern Italy and guide future research. The EGFR and KRAS mutations in NSCLC resected patients from Southern Italy showed a global similar incidence compared to other recently described Italian cohorts of advanced and early-stage NSCLC, with a higher frequency of exon19 EGFR deletions. No prognostic impact was observed for both EGFR and KRAS status, but additional investigations on a larger cohort are needed.

P2/3, N=174, Active, not recruiting, SWOG Cancer Research Network | Trial completion date: Dec 2024 --> Jun 2025

EGFR mutation subtypes and co-mutations differ by race. KMT2C may influence TMB and immunotherapy response, while GLI1 is linked to TKI resistance. TP53 alterations were more commen in smokers, and patients with high PDL-1 and TMB, highlighting additional factors that drive tumors with these alterations.

Our findings suggest that the combination of afatinib and bevacizumab may offer long-term clinical benefits for LUAC patients harboring the novel and rare EGFR Q787L mutation. This case highlights a potential therapeutic strategy warranting further investigation in clinical studies.

This work revealed the mutational landscape and characteristics of 30 core driver genes in a LUAD cohort. Co-mutated genes and genes associated with gender and age indicate their different roles in the corresponding subgroup of the LUAD.

Initial treatment with afatinib yielded a favorable tumor response for 18 months, but disease progression ensued. In this case, although the postoperative observation period is still short, salvage lung resection suggests the possibility of leading to favorable disease control. With a thorough evaluation of surgical indications and appropriate management of several complications associated with the prior treatment, salvage surgery can be a valuable and viable option for selected patients.

P1/2, N=334, Active, not recruiting, Takeda | Trial completion date: Mar 2025 --> Oct 2026 | Trial primary completion date: Mar 2025 --> Oct 2026

P1, N=60, Recruiting, Karen Reckamp, MD, MS | Trial completion date: Jan 2026 --> Jan 2028 | Trial primary completion date: Jan 2025 --> Jan 2027

P1, N=105, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Apr 2025 --> Oct 2025 | Trial primary completion date: Apr 2025 --> Oct 2025

P2, N=200, Recruiting, Janssen Research & Development, LLC | Active, not recruiting --> Recruiting

We propose that patients with EGFR Ex19del mutation and MET de novo amplification may benefit more from dual-targeted therapy than pemetrexed and carboplatin chemotherapy along with bevacizumab. Timely intervention is needed to avoid greater harm when ILD occurs and, when ILD is effectively controlled, seize the opportunity to rechallenge the dual-targeted therapy may contribute to a better prognosis. In addition, the patients with targeted-induced ILD in the past need more rigorous monitoring and follow-up in the process of rechallenging the targeted drug therapy.

Outcomes from routine treatment with erlotinib and gefitinib in New Zealand patients with advanced EGFR-mutant nonsquamous non-small cell lung cancer are comparable with those reported in randomized trials and other health care system-wide retrospective cohort studies. Socioeconomic status, EGFR mutation subtype, and disease extent at cancer diagnosis were independent predictors of treatment outcomes in that setting.

P2, N=201, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting

P1, N=701, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Feb 2025 --> Jun 2026

P3, N=674, Active, not recruiting, AstraZeneca | Trial completion date: Jan 2025 --> Dec 2025

With satisfying prognosis benefits and acceptable brain metastasis rate in long-term follow-up, gefitinib exhibited clinical viability for operable stage II-IIIA EGFR-mutant NSCLC over chemotherapy in the neoadjuvant setting. MPR was significantly associated with both prolonged DFS and OS, manifesting its potential as an essential endpoint for future neoadjuvant trials.

P1, N=30, Recruiting, City of Hope Medical Center | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Oct 2026 --> Oct 2027

P2, N=50, Recruiting, Goethe University | Trial primary completion date: Nov 2023 --> Nov 2025

We tracked the phylogenetic history of an EGFR mutant lung cancer treated with erlotinib, osimertinib, radiotherapy and a personalized neopeptide vaccine (NPV) targeting ten somatic mutations, including EGFR exon 19 deletion (ex19del). Data from the TRACERx 421 cohort3 provide evidence that pre-WGD mutations better represent clonal variants, and owing to their presence at multiple copy numbers, are less likely to be lost in metastatic transition. These data highlight the power of phylogenetic disease tracking and functional T cell profiling to understand mechanisms of immune escape during combination therapies.

P2, N=100, Active, not recruiting, National Taiwan University Hospital | Recruiting --> Active, not recruiting | Trial completion date: Jul 2026 --> Oct 2027 | Trial primary completion date: Jul 2024 --> Oct 2026