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NCT Number: NCT07823855

SIB Accelerated Hyperfractionated RT for High-Proliferation NSCLC

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).

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Key information

Conditions

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 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Hyperfractionated Radiotherapy

Radiation

simultaneous integrated boost accelerated hyperfractionated radiotherapy

Primary outcomes

  1. Incidence of Acute Treatment-Related Toxicity

    Time frame: From the start of radiotherapy through 90 days after completion of radiotherapy.

    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.

  2. Incidence of Late Treatment-Related Toxicity

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

    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.

Secondary outcomes

  1. Objective Response Rate (ORR)

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

    Objective response rate is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

  2. Progression-Free Survival (PFS)

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

    Progression-free survival is defined as the time from enrollment to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed according to RECIST version 1.1.

  3. Overall Survival (OS)

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

    Overall survival is defined as the time from enrollment to death from any cause.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Registry information

Official study title

A Single-arm Phase I/II Clinical Study of Simultaneous Integrated Boost Accelerated Hyperfractionated Radiotherapy for High-proliferation Non-small Cell Lung Cancer

Acronym: HP-SIB-AHFRT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

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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