Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT

Phase 2

Recruiting

• Conditions: Locally Advanced Non-Small Cell Lung Cancer; Thoracic Radiotherapy; Safety
• Interventions: Drug: Anlotinib

• Registration Number: NCT07037680
• Lead Sponsor: JIANYANG WANG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-06-23
• Study First Posted: 2025-06-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy plus Anlotinib	Anlotinib	Radiotherapy plus anlotinib in LA-NSCLC intolerable to cCRT

Primary Outcome Measures

Name	Time	Method
2-year progression-free survival (PFS)	From the first day of radiotherapy to the occurrence of objective tumor progression or death due to any cause, whichever occurs first, assessed up to 60 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival(OS)	From the first day of radiotherapy to the occurrence of death due to any cause, assessed up to 60 months
Local regional recurrence (LR)	From the first day of radiotherapy to the occurrence of clinical and/or biopsy-proven recurrence within the bronchial stump, ipsilateral hilum, mediastinum, or supraclavicular, whichever occurs first, assessed up to 60 months
Distant metastasis (DM)	From the first day of radiotherapy to the occurrence of any evidence of metastatic disease beyond the locoregional regions previously mentioned, assessed up to 60 months
Acute toxicity	From the first day of radiotherapy and up to the 3-month post-radiotherapy follow-up visit

Trial Locations

Locations (1)

Department of Radiation Oncology,Cancer Institute and Hospital,Chinese; 🇨🇳 Beijing, Beijing, China