Hypofraction Radiotherapy for Locally Advanced Non-small Cell Lung Cancer

NCT05269485 | Completed Phase 2

• 1 other identifier: ky270
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Definitive concurrent chemoradiotherapy followed by durvalumab (Pacific protocol) has been the standard modality for stage III locally advanced non-small cell lung cancer. In spite of the median overall survival of 47.5 months, there still existed 38.5% and 6.9% patients who finally developed intra-thorax and extra-thorax recurrence respectively in long-term follow-up. The relatively low local control rate has been the bottleneck for further improvement of overall survival. Hypofraction radiotherapy has been validated to be able to increase the local control rate in two prospective trials. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy followed by immune checkpoint inhibitors for stage III locally advanced non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer; Radiotherapy Side Effect

Keywords

hypofraction radiotherapy; non-small cell lung cancer; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (4)

• Rate of radiation-induced pneumonitis (CTCAE V4.0)

  Rate of radiation-induced pneumonitis (CTCAE V4.0)

  1 to 2 years

• Rate of radiation-induced esophagitis (CTCAE V4.0)

  Rate of radiation-induced esophagitis (CTCAE V4.0)

  1 to 2 years

• Rate of central hilar structure injury (CTCAE V4.0)

  Rate of central hilar structure injury (CTCAE V4.0)

  1 to 2 years

• Rate of hematologic toxicity

  Rate of hematologic toxicity

  1 to 2 years

Secondary Outcomes (7)

• Median overall survival (RECIST 1.1)

  1-2 year

• 2-year overall survival rate (RECIST 1.1)

  2 year

• Median progression-free survival (RECIST 1.1)

  1-2 year

• 2-year progression-free survival rate (RECIST 1.1)

  2 year

• Objective response rate

  3 months after radiotherapy

Study Arms (2)

High-dose Arm

EXPERIMENTAL

Irradiation of 60Gy/15f is administered followed by one-year immunotherapy maintenance.

Radiation: High-dose hypofractionated radiotherapy

Low-dose Arm

EXPERIMENTAL

Irradiation of 48Gy/12f is administered followed by one-year immunotherapy maintenance.

Radiation: Low-dose hypofractionated radiotherapy

Interventions

High-dose hypofractionated radiotherapy RADIATION

Patients in this arm would receive high-dose fractionated radiotherapy with 60Gy/15f with one-year immunotherapy maintenance.

High-dose Arm

Low-dose hypofractionated radiotherapy RADIATION

Patients in this arm would receive high-dose fractionated radiotherapy with 48Gy/12f with one-year immunotherapy maintenance.

Low-dose Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old;
• Eastern Cooperative Oncology Group (ECOG) 0-1;
• Non-small cell lung cancer including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma, large-cell carcinoma;
• Wild-type of driven genes;
• Stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and d Positron Emission Tomography (PET-CT);
• Surgically unresectable or deny of surgery;
• Signature of inform consent.

You may not qualify if:

• Younger than 18 years old or older than 70 years old;
• ECOG\>1;
• Small-cell lung cancer and other neuroendocrine carcinoma including typical or atypical carcinoid, large-cell neuroendocrine carcinoma;
• Mutant type of driven genes;
• Non-stage III (AJCC 8th Edition) confirmed by cranial MRI, chest CT, abdominal ultrasonograph, bone scan or cranial MRI and PET-CT;
• Surgically resectable;
• No signature of inform consent.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provicial Hospital

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Radiation Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Radiotherapy

Model Details: There are two parallel group with each of 18 patients. One group would receive high-dose hypofraction radiotherapy of 60Gy/15f and the other group would receive low-dose hypofraction radiotherapy of 48Gy/12f.

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 8, 2022
• Study Start: March 1, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)