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NCT07458919

EARLY_PHASE1

Therapy for Advanced NSCLC With EGFR 19delins Mutation

Sponsor: Fuzhou General Hospital

View on ClinicalTrials.gov

Summary

In a retrospective analysis of 3,054 advanced NSCLC patients, 41 with EGFR exon 19 deletion-insertions (19delins) received first-generation EGFR TKIs, achieving median PFS of 10.4 months; those with L747\_T751delinsP had notably longer PFS of 18.7 months. Another study of 2,467 treatment-naïve patients found 93 with 19delins treated with first-generation TKIs had median PFS of 19 months, exceeding the 13 months for common 19del mutations. For third-generation TKIs, a study of 215 19delins patients (57 first-line) showed median PFS of 12.9 months, inferior to 23.2 months for common 19del. Our center's retrospective study of 4,666 NSCLC patients in Fujian (2017-2020) included 69 with 19delins: median PFS was 16.7 months with first-generation TKIs versus 7.2 months with third-generation. Evidence suggests specific EGFR deletion locations may affect TKI efficacy; first-generation TKIs may be superior in some 19delins subtypes, while third-generation appear limited. Large prospective data are lacking. This project aims to compare first- versus third-generation EGFR TKIs in 19delins patients via a randomized controlled trial, stratify sensitivity by subtype, and improve survival.

Official title: A Comparative Study on the Efficacy of First-generation Versus Third-generation EGFR TKIs as First-line Therapy for Advanced NSCLC With EGFR Exon 19 Deletion-insertion (19delins) Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-30

Completion Date

2030-10-30

Last Updated

2026-03-09

Healthy Volunteers

Conditions

Lung Cancer

Interventions

DRUG

Icotinib/Gefitinib

To explore the efficacy of first-generation EGFR TKIs versus third-generation EGFR TKIs in the first-line treatment of advanced NSCLC with EGFR 19delins mutation.

Inclusion Criteria: * Age ≥ 18 years; * Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) (AJCC Cancer Staging Manual, 9th edition, Stage IIIB, IIIC or IV) that is not amenable or suitable for surgical resection or other radical therapies, as assessed by the investigator; * Epidermal growth factor receptor (EGFR) exon 19 deletion-insertion mutation (19delins) documented by testing of tumor tissue or plasma samples using methods including IHC, NGS, ARMS, etc.; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1; * No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; * Life expectancy ≥ 12 months; * At least one measurable lesion by imaging in the screening period according to RECIST v1.1; * Ability to swallow and retain oral medication; * Adequate organ system function; * Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study treatment, and agree to use a medically accepted highly effective method of contraception during the study and for 3 months after the last dose of study drug; * Voluntary and able to comply with study and follow-up procedures; Ability to understand the nature of the trial and provide written informed consent. Exclusion Criteria: * Advanced and/or symptomatic brain metastases (measurable or non-measurable) and/or leptomeningeal metastases; * Active hepatitis B, positive for hepatitis C virus antibody, positive for human immunodeficiency virus (HIV) antibody, or positive for Treponema pallidum antibody; * Women of childbearing potential with a positive serum pregnancy test within 7 days prior to initiation of treatment, pregnant or lactating women, or male and female subjects who are not using effective contraception or plan to conceive during the entire treatment period and for 3 months after the end of treatment; * Patients who have used any of the following medications within 14 days prior to the first dose or require concomitant use of such medications during treatment: drugs with a risk of causing QTc prolongation and/or torsade de pointes; strong inhibitors or strong inducers of CYP3A; * Underwent major surgery or immunotherapy within 4 weeks prior to the first dose; received radiation therapy within 2 weeks prior to the first dose; * Patients with imaging evidence of tumor invasion of major blood vessels, or those judged to have a very high likelihood of tumor invasion of critical blood vessels leading to fatal massive hemorrhage during the subsequent study period; * History of interstitial lung disease, drug-induced interstitial disease, or any clinically evident active interstitial lung disease; presence of idiopathic pulmonary fibrosis on baseline CT scan; * Other severe, acute, or chronic medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results, including uncontrolled diabetes mellitus, medical or psychiatric illnesses, or laboratory abnormalities; * Any other conditions deemed by the investigator to make the subject unsuitable for participation in this trial.