Radiation treatment followed by benmelstobart injection plus anlotinib before surgery for people with stage two to stage three epidermal growth factor receptor–positive non–small cell lung cancer

Stereotactic body radiation therapy followed sequentially by benmelstobart injection combined with anlotinib as neoadjuvant treatment for stage II to stage III epidermal growth factor receptor–positive non–small cell lung cancer: a single-arm, multicenter, phase two clinical study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12898215

Enrollment

Registered

2026-02-02

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoadjuvant treatment for stage II-III epidermal growth factor receptor–positive non–small cell lung cancer Cancer

Interventions

After signing the informed consent form and being confirmed as eligible according to the inclusion and exclusion criteria, participants will receive a 3-day course of stereotactic body radiation thera

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with previously untreated stage II to stage III non–small cell lung cancer confirmed by cytology and/or histology. 2. Positive for an epidermal growth factor receptor mutation. 3. Pulmonary lesions considered resectable or potentially resectable after discussion by a multidisciplinary team with thoracic surgery involvement. 4. Eastern Cooperative Oncology Group performance status score of 0 to 1.

Exclusion criteria

Exclusion criteria: 1.The patient has, or is suspected of having, an autoimmune disease. 2.The patient is expected to require systemic corticosteroid therapy within 14 days after enrollment. 3.Patients with grade 3 to 4 interstitial lung disease. 4.Concurrent other malignancy requiring antitumor treatment. 5.Imaging (computed tomography or magnetic resonance imaging) shows that the tumor lesion is within 5 millimeters of a major blood vessel, invades local major blood vessels, or is a central tumor located within 2 centimeters of the bronchus; or there is an obvious cavitary or necrotic lung tumor. 6.Clinically significant hemoptysis within 2 weeks prior to enrollment (more than 50 milliliters per day) or other clinically significant bleeding symptoms, or a definite bleeding tendency. 7.Imaging shows tumor involvement around critical vessels, or in the investigator’s judgment the tumor is highly likely to invade critical vessels during the study, posing a risk of fatal massive hemorrhage. 8.Arterial or venous thrombotic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.

Countries

China

Contacts

Public ContactWeidong Wang

wangweid@sysucc.org.cn+86 18958120479

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026