SIB Accelerated Hyperfractionated RT for High-Proliferation NSCLC

NCT07823855 | Recruiting

• 1 other identifier: 2026-0539
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, single-center phase I/II clinical trial evaluating the safety, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of simultaneous integrated boost accelerated hyperfractionated radiotherapy in patients with high-proliferation non-small cell lung cancer (NSCLC).

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer; hyperfractionated radiotherapy

Outcome Measures

Primary Outcomes (2)

• Incidence of Acute Treatment-Related Toxicity

  The incidence and severity of acute treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

  From the start of radiotherapy through 90 days after completion of radiotherapy.

• Incidence of Late Treatment-Related Toxicity

  The incidence and severity of late treatment-related toxicities will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

  From more than 90 days after completion of radiotherapy through 2 years after completion of radiotherapy.

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Every 3 months after completion of radiotherapy, up to 2 years.

• Progression-Free Survival (PFS)

  From enrollment until documented disease progression or death from any cause, up to 2 years.

• Overall Survival (OS)

  From enrollment until death from any cause, up to 2 years.

Study Arms (1)

hyperfractionated radiotherapy

EXPERIMENTAL

simultaneous integrated boost accelerated hyperfractionated radiotherapy

Radiation: hyperfractionated radiotherapy

Interventions

hyperfractionated radiotherapy RADIATION

simultaneous integrated boost accelerated hyperfractionated radiotherapy

hyperfractionated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, male or female;
• Histologically or cytologically confirmed high-proliferation non-small cell lung cancer (NSCLC);
• Assessed by a multidisciplinary team (MDT) and planned to receive thoracic radiotherapy (either curative or palliative), regardless of stage.

You may not qualify if:

• Small cell histology;
• Severe cardiac disease (New York Heart Association \[NYHA\] functional class ≥ III, uncontrolled arrhythmia, or myocardial infarction within the past 6 months);
• Pregnant or breastfeeding women, or patients of childbearing potential who are unwilling to use effective contraceptive measures;
• Concurrent participation in other interventional clinical trials;
• Other conditions deemed by the investigator to make the patient unsuitable for enrollment (e.g., severe mental illness).

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ting Zhang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Wang

CONTACT

+86 057137826869; dluwang0727@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: September 16, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): June 16, 2028
• Study Completion (Estimated): June 16, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-07

Locations

CN (1)