Comparison of the efficacy of stereotactic ablative radiotherapy combined with immunotherapy versus surgical treatment in patients with early-stage or lymph node-negative isolated recurrent non-small cell lung cancer: A prospective, multicenter, randomized, open-label, controlled Phase II clinical study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500102631

Enrollment

Unknown

Registered

2025-05-16

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-05-19

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

Conditions

Early-Stage or Lymph Node-Negative Isolated Recurrent Non-Small Cell Lung Cancer

Interventions

experimental group:I-SABR

Control group:Surgical treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1?Age >= 18 years; 2?Pathologically confirmed NSCLC, clinically diagnosed as early-stage or isolated pulmonary parenchymal recurrence of lymph node-negative NSCLC. According to the 9th edition of the American Joint Committee on Cancer (AJCC) staging system, early-stage is defined as stage IA-IB (tumor size 5 cm and <= 7 cm, N0, M0). Multiple primary lung cancers are allowed. At the initial diagnosis, staging should be TanyNanyM0, and at recurrence, it should be a lymph node-negative pulmonary parenchymal isolated recurrence (recurrent tumor size <= 7 cm), with a minimum interval of 6 months between the prior treatment and the SABR treatment; 3?Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4?At least one evaluable lesion meeting the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; 5? Non-squamous cancer tissue specimens need to undergo epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) fusion testing;

Exclusion criteria

Exclusion criteria: 1?Clinically, if two or more deputy chief physicians or higher-level radiation oncology experts consider the patient not to meet the SABR criteria, or if two or more deputy chief physicians or higher-level thoracic surgery experts consider the patient not to meet the surgical treatment criteria; 2?Presence of other malignant tumors; 3?Any additional planned pre-treatment or systemic therapy; 4?Failure to meet the minimum SABR dose-volume constraints; 5?Presence of EGFR mutations or ALK fusions; 6?History of autoimmune diseases; 7?Presence of IT-related contraindications;

Design outcomes

Primary

Measure	Time frame
Event-Free Survival;	—

Secondary

Measure	Time frame
Local Control Rate;Objective Response Rate;Adverse event rate;Distant metastasis rate;Quality of Life;Overall Survival;	—

Countries

China

Contacts

Public ContactLin Zheng

Taizhou Cancer Hospital

y215180575@zju.edu.cn+86 15258602261

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026