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NCT Number: NCT07037680

Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT

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.

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Key information

Conditions

Locally Advanced Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Safety Thoracic Neoplasms Thoracic Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Radiation Oncology,Cancer Institute and Hospital,Chinese

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

jianyang wang

CONTACT

[email protected]

+8613810095191

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • ≥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 criteria

  • 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.

Treatment and study plan

Anlotinib

Drug

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.

Primary outcomes

  1. 2-year progression-free survival (PFS)

    Time frame: 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 outcomes

  1. Overall Survival(OS)

    Time frame: From the first day of radiotherapy to the occurrence of death due to any cause, assessed up to 60 months

  2. Local regional recurrence (LR)

    Time frame: 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

  3. Distant metastasis (DM)

    Time frame: 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

  4. Acute toxicity

    Time frame: From the first day of radiotherapy and up to the 3-month post-radiotherapy follow-up visit

Study contacts

Contact information is provided by the study sponsor or research team.

jianyang wang, MD

CONTACT

[email protected]

+86-13810095191

Sponsors and collaborators

Lead sponsor

JIANYANG WANG

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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