Spatial Fragmentation Combined With Low-dose Radiotherapy for Immunotherapy Combined With Chemotherapy-resistant Locally Advanced or Advanced Non-small Cell Lung Cancer

NCT06775678 | Recruiting Phase 2

• 1 other identifier: E20240009
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the effect of immunotherapy combined with spatial fractionation radiotherapy and low dose radiotherapy on the prognosis of patients with advanced lung cancer under specific dose regimens (spatial fractionation radiotherapy: high dose region: 800-1200cGy × 3f, low dose region: 100-300cGy × 5f; low dose radiotherapy area: 100-300cGy × 5f). Through the phase II clinical trial, to determine the efficacy and safety of the combined treatment model in advanced lung cancer and its effect on the immune microenvironment of patients, so as to provide scientific basis for the optimization of treatment regimen for advanced lung cancer.

Conditions

Lung Cancers; Radiation Treatment for Tumors

Keywords

Spatially Fractionated Radiation Treatment; low dose radiotherapy; Lung Cancers; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  From enrollment to the end of treatment at 6 mouths

Secondary Outcomes (4)

• Disease control rate

  From enrollment to the end of treatment at 6 mouths

• Progression free survival

  From enrollment to the end of treatment at 6 mouths

• Overall survival

  From enrollment to the end of treatment at 6 mouths

• Adverse Event

  From enrollment to the end of treatment at 6 mouths

Study Arms (2)

experimental group

EXPERIMENTAL

1. Patients received dose-specific irradiation using a medical linear accelerator to create each sphere of approximately 0.5 to 1.5 cm in diameter within the gross tumour volume (GTV) of the largest tumour, with spheres spaced 2.0 to 5.0 cm apart from each other as the high-dose area; the rest of the GTV was used as the low-dose area. For a single lesion, spatially divided radiotherapy was given, with the prescribed dose for the high-dose area: 800-1200cGy×3f, and the prescribed dose for the low-dose area: 100-300cGy×5f; all the remaining irradiable metastatic foci were given low-dose radiotherapy (palliative radiotherapy was given to the brain and bone metastases in accordance with the clinical routine, and was excluded from the scope of low-dose radiotherapy), with the prescribed dos 2. During or within 1 week after radiotherapy, chemotherapy combined with immunotherapy was carried out according to the physical, pathological and genetic detection of the patients.

Radiation: Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy

control group

ACTIVE COMPARATOR

The control group only received conventional radiotherapy for chest or other lesions, followed by immunotherapy and chemotherapy according to the tumor stage, tolerance and genetic characteristics of the patients

Radiation: Conventional fractionated radiotherapy

Interventions

Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy RADIATION

Spatially Fractionated Radiation Therapy Combined With Low-dose Radiotherapy

experimental group

Conventional fractionated radiotherapy RADIATION

Conventional fractionated radiotherapy

control group

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent form.
• Be at least 18 years old.
• Have a Karnofsky Performance Status (KPS) score of 70 or higher and an expected survival of more than 3 months.
• Have histopathological evidence of small cell lung cancer, lung adenocarcinoma, or lung squamous cell carcinoma.
• Have received prior immunotherapy and experienced disease progression.
• The site targeted for radiotherapy has not been previously irradiated or it has been at least 6 months since the last radiotherapy.

You may not qualify if:

• The patient has lesions that are not suitable for radiotherapy: malignant pleural effusion, ascites, meningeal metastasis, etc.
• The patient has other serious comorbidities, such as myocardial infarction occurring within 6 months, severe arrhythmia, mental illness, etc., is unable to complete the treatment, or has an expected survival period of less than 3 months.
• The patient has severe organ dysfunction, such as liver failure, cardiopulmonary failure, etc., and is difficult to tolerate radiotherapy.
• The patient currently has a severe infection.
• The patient has a known or suspected active autoimmune disease (congenital or acquired), such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. (Patients with vitiligo or those with cured childhood asthma can be included; patients with type 1 diabetes who have good insulin control can also be included).
• The patient has experienced grade 3 or above cardiac or liver toxicity reactions or grade 4 toxicity reactions in other organs during previous immunotherapy.
• Other situations where reviewers consider there are sufficient reasons for disqualification from the registered study: such as potential situations inconsistent with the clinical protocol.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Ningbo Liu, doctor

CONTACT

+86 15602036608; liuningbo@tjmuch.com

Ningbo Liu, doctor

CONTACT

+8615602036608

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 15, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 28, 2028
• Last Updated: June 17, 2025

Record last verified: 2025-05

Locations

CN (1)