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

Inclusion Criteria9

Patients with histologically or cytologically confirmed negative EGFR (including EGFR exon 19 deletion or L858R mutations) or ALK/ROS1-mutated locally advanced unresectable NSCLC were screened.
≥18 years old with no restrictions on sex;
Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;
Eastern cooperative oncology group (ECOG) score ≤2 was required;
Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;
No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk;
No symptoms of hemoptysis;
Adequate hepatic and renal functions with a negative urine protein;
Expected survival of more than 6 months.

Exclusion Criteria6

currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ;
previous malignancy within five years;
thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months;
uncontrolled or active pulmonary inflammation;
participated in other clinical trials;
Pregnant women.

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.