NCT07037680

Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT

Efficiency and Safety of Radiotherapy Combined With Anlotinib in Locally Advanced Non-small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: A Phase II Single-arm Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: JIANYANG WANG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.

Conditions

• Locally Advanced Non-Small Cell Lung Cancer
• Thoracic Radiotherapy
• Safety

Interventions

Type	Name	Description
DRUG	Anlotinib	For patients treated with conventional Intensity-Modulated Radiation Therapy (IMRT), the median prescribed dose was 60 Gy/30 fractions (range: 50.0-70.0 Gy, in 25-35 fractions) (median BED10 72 Gy, range: 60-84 Gy) to the planning target volume (PTV). As for patients with IMRT-based simultaneously integrated boost (SIB), the median prescribed dose was 59.92 Gy/28 fractions (range: 50.0-70.0 Gy, in 25-33 fractions) (median BED10 72.74 Gy, range: 60-84 Gy) to the planning gross tumor volume (PGTV), and 50.4 Gy/28 fractions (range: 45-59.4 Gy, in 25-33 fractions) (median BED10 59.47 Gy, range: 53.1-70.1 Gy) to the PTV. It should be noted that the PTV in the SIB group contains the PGTV. Anlotinib was administered orally concurrently with the first day of radiotherapy, at a dose of 12 mg for a maximum of three cycles. Each cycle was defined as 2 weeks on-treatment followed by 1 week off-treatment. If intolerance occurs, the dose may be reduced to 8-10 mg/day or stopped.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-06-30
• First posted: 2025-06-25
• Last updated: 2025-07-09

Locations

1 site across 1 country: China