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

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.

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.

Inclusion Criteria:

1. ≥18 years old with no restrictions on sex;
2. Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;
3. Eastern cooperative oncology group (ECOG) score ≤2 was required;
4. Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;
5. .No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk;
6. No symptoms of hemoptysis;
7. Adequate hepatic and renal functions with a negative urine protein;
8. Expected survival of more than 6 months.

Exclusion Criteria:

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