RecruitingPhase 2NCT07037680

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

Sponsor

JIANYANG WANG

Enrollment

44 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Safety Locally Advanced Non-Small Cell Lung Cancer Thoracic Radiotherapy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding anlotinib (a drug that blocks tumor blood vessel growth) to radiation therapy improves outcomes in patients with locally advanced non-small cell lung cancer (NSCLC) who cannot tolerate standard chemotherapy combined with radiation. **You may be eligible if...** - You are 18 years old or older - You have locally advanced NSCLC confirmed by biopsy - Your cancer does not have EGFR or ALK/ROS1 mutations - You are unable to tolerate concurrent chemotherapy with radiation **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have uncontrolled high blood pressure or bleeding disorders - You have already received radiation to the chest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib

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.