Abstract
BackgroundDurvalumab is a standard drug used during maintenance therapy after chemoradiotherapy in patients with locally advanced non-small cell lung cancer (LA-NSCLC). However, little is known about the clinical benefits of durvalumab after chemoradiotherapy in patients with LA-NSCLC with a performance status (PS) of 2 and/or aged > 75 years. As daily carboplatin plus concurrent thoracic radiotherapy is recommended for elderly patients according to guideline, the current phase II study aims to investigate the effect of daily carboplatin plus radiotherapy followed by durvalumab for patients with stage III NSCLC who have a PS of 2 and/or are older.MethodsDaily carboplatin plus radiotherapy followed by durvalumab is performed for the patients with stage III NSCLC who have a PS of 2 and/or are older. This is a trial in progress manuscript.Study treatmentDaily, intravenous, low-dose carboplatin (30 mg/m2 in a 30-min infusion) is administered to patients 1 h before radiotherapy for the first 20 fractions. Radiotherapy for all patients consisted of 60 Gy administered as 30 fractions over 6 weeks. Durvalumab at a dose of 10 mg/kg/body is intravenously administered every 2 weeks for up to 12 months after chemoradiotherapy.Exploratory assessmentIn the future, an exploratory investigation will be performed to determine whether the combined assessment of T-cell markers, PD-L1 expression, and tumor mutation burden could predict the outcomes of the regimen.DiscussionThe results of our study will exhibit the efficacy and tolerability of durvalumab as maintenance therapy after daily carboplatin plus radiotherapy.Trial registrationDuring the first registration (before induction chemoradiotherapy), 70 patients will be included; then, we include 58 patients during the second registration (before durvalumab treatment after chemoradiotherapy). https://jcrb.niph.go.jp/.Primary endpointThe primary endpoint of the current study is the 12-month progression-free survival (PFS) rate after the initiation of durvalumab.Secondary endpointsThe secondary endpoints are the feasibility, objective response, PFS, overall survival, and adverse events.
Highlights
Durvalumab is a standard drug used during maintenance therapy after chemoradiotherapy in patients with locally advanced non-small cell lung cancer (LA-NSCLC)
The JCOG0301 study demonstrated that the 5-year survival rate was approximately 15%, which was less than 20%, observed in elderly patients with LA-NSCLC who received daily carboplatin plus concurrent radiotherapy [11]
Anti-programmed death 1 (PD-1)/ progressive disease (PD)-L1 antibodies result in a significant survival benefit for patients with advanced NSCLC with a good performance status (PS) [18], the efficacy of immune checkpoint inhibitors (ICIs) is known to increase after radiotherapy [19]; a synergistic effect is expected for patients with a PS of 2
Summary
Durvalumab is a standard drug used during maintenance therapy after chemoradiotherapy in patients with locally advanced non-small cell lung cancer (LA-NSCLC). Little is known about the clinical benefits of durvalumab after chemoradiotherapy in patients with LA-NSCLC with a performance status (PS) of 2 and/or aged > 75 years. Chemoradiotherapy is a standard treatment for patients with locally advanced stage III non-small cell lung cancer (NSCLC). Chemoradiotherapy has not been widely applicable for patients with locally advanced NSCLC (LA-NSCLC). Most patients with a performance status (PS) of 0 to 1 and aged less than 70 years receive chemoradiotherapy [1,2,3,4,5]. The outcomes of these patients are poor, with a 5-year survival rate of < 10% compared to the 5-year survival rate of approximately 15% observed when patients receive chemoradiotherapy [6, 7]
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