Abstract
BackgroundConcurrent chemo-radiotherapy remains the standard treatment in unresectable stage III non-small-cell lung cancer (NSCLC) patients. Several studies have shown a potential value of concurrent epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with thoracic radiotherapy in EGFR-mutated population, but a high risk of radiation pneumonitis raised a major concern. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI, with radiotherapy in locally advanced EGFR-mutated NSCLC patients.MethodsLocally advanced NSCLC patients harboring sensitive EGFR mutation will be included in this study. A radiotherapy plan will be made for each patient before treatment, and the lung V20 will be calculated. Patients with lung V20 ≥ 28% were enrolled in induction group (arm A), which almonertinib was given for 2 months followed by concurrent radiotherapy; patients with lung V20 < 28% were enrolled in concurrent group (arm B), which almonertinib was given concurrent with thoracic radiotherapy. The primary endpoint is the incidence of grade ≥ 3 radiation pneumonitis within 6 months post-radiotherapy, and the secondary endpoints are local control rate, progression-free survival, and overall survival.DiscussionThe safety and efficacy of third-generation EGFR-TKI concurrent with thoracic radiotherapy in locally advanced EGFR-mutated NSCLC is still unknown. We propose to conduct this phase 2 study evaluating the safety especially the radiation pneumonitis within 6 months post-radiotherapy. This trial protocol has been approved by the Ethics committee of Hangzhou cancer hospital. The ethics number is HZCH-2020-030.Trial registrationclinicaltrials.gov, NCT04636593. Registered 19 November 2020 - Retrospectively registered
Highlights
Concurrent chemo-radiotherapy remains the standard treatment in unresectable stage III non-smallcell lung cancer (NSCLC) patients
In order to reduce the influence of large plan target volume (PTV) on radiation pneumonitis, patients with lung V20 ≥ 28% were enrolled in induction group, which almonertinib was given for 2 months followed by concurrent radiotherapy; patients with lung V20 < 28% were enrolled in concurrent group, which almonertinib was given concurrent with thoracic radiotherapy (Fig. 1)
The main purpose of this study is to explore the safety of third-generation Epidermal growth factor receptor (EGFR)-Tyrosine kinase inhibitor (TKI) almonertinib combined with radiotherapy for stage III NSCLC patients
Summary
Concurrent chemo-radiotherapy remains the standard treatment in unresectable stage III non-smallcell lung cancer (NSCLC) patients. Several studies have shown a potential value of concurrent epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with thoracic radiotherapy in EGFR-mutated population, but a high risk of radiation pneumonitis raised a major concern. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI, with radiotherapy in locally advanced EGFR-mutated NSCLC patients. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases and 30% of NSCLC patients are in stage III. The standard treatment for local advanced NSCLC is still doublet platinum-based therapy combined with radiotherapy, regardless of the EGFR mutation status. Many efforts including escalation of radiation dose, adjustment of chemotherapy regimen or sequence have been made to improve the outcome of local advanced NSCLC, but little progress was made. Subgroup analysis showed that patients with EGFR mutations might not benefit from maintenance immunotherapy
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