Assessing furmonertinib for lung cancer patients with specific mutations after surgery

A Phase II, Prospective, Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor 20ins Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

This study is testing if a new drug called furmonertinib can help lung cancer patients with specific mutations stay cancer-free after their surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Cancer Hospital and Research Institute (Academic / other)
• Drugs / interventions: chemotherapy, radiation, furmonertinib
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06192849 on ClinicalTrials.gov

What this trial studies

This phase II, prospective, multi-centre study evaluates the efficacy and safety of furmonertinib in patients with epidermal growth factor receptor (EGFR) 20 insertion mutation positive stage IB-IIIA non-small cell lung carcinoma (NSCLC) following complete tumor resection. The study aims to enroll 20 subjects who will receive furmonertinib at a dosage of 160mg per day until disease recurrence, death, or intolerability, with a maximum treatment duration of three years. The primary endpoint is disease-free survival (DFS), while secondary endpoints include DFS rate, overall survival (OS), and changes in health-related quality of life (HRQoL). Additionally, peripheral blood ctDNA will be collected and analyzed throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage IB, II, or IIIA non-small cell lung carcinoma who have undergone complete surgical resection and have an EGFR 20 insertion mutation.

Not a fit: Patients who have had only segmentectomies or wedge resections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease-free survival and overall outcomes for patients with a specific mutation in lung cancer.

How similar studies have performed: Other studies have shown promising results with targeted therapies for specific mutations in lung cancer, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Provide informed consent prior to any study specific procedures;
* Male or female, aged at least 18 years;
* Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for the tumor;
* Patients must be classified post-operatively as Stage IB, II, or IIIA on the basis of pathologic criteria;
* Complete recovery from surgery and standard post-operative therapy (if applicable);
* Patient with EGFR 20 insertion mutation diagnosed histologically or cytologically, the reports must be issued or recognized by Tier 3A hospitals;
* ECOG PS of 0 to 1;
* For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;

Exclusion Criteria:

* Patients who have had only segmentectomies or wedge resections;
* Any prior anticancer therapy（excluding adjuvant platinum-based chemotherapy）;
* Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4;
* Treatment with an investigational drug within five half-lives of the compound or any of its related material;
* History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for \> 5 years following the end of treatment;
* Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy;
* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV);
* Mean resting corrected QT interval (QTc) \>470 msec, obtained from 3 ECGs, using the screening clinic ECG Machine-derived QTc value;
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval;
* Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD;
* Inadequate bone marrow reserve or organ function;

Where this trial is running

Chengdu, Sichuan

• Sichuan cancer hospital — Chengdu, Sichuan, China (Recruiting)

Conditions Non Small Cell Lung Cancer; EGFR Exon 20 Insertion Mutation