Hybrid Dose-fraction Radiotherapy for Metastatic Non-small Cell Lung Cancer

NCT05348668 | Completed Phase 2

• 1 other identifier: 2021-ky301
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The combination of immune checkpoint inhibitors (ICI) and local ablative radiotherapy has been demonstrated to be able to increase the survival of patients with metastatic driven-genes negative non-small cell lung cancer. Various dose-fraction of radiotherapy could exert different effects on the immune system. Ablative-dose could induce immunogenic cell death through the activation of CD8+(Cluster of Differentiation) T cells. Low-dose could modulate immune microenvironment from immunosuppression to inflammatory anti-tumor phenotype. This trial is designed to validation the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.

Conditions

Non-Small Cell Lung Cancer

Keywords

metastatic driven-genes negative non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free Survival evaluated by RECIST (v1.1)

  1-year

Study Arms (1)

Hybrid dose-fraction Radiotherapy Arm

EXPERIMENTAL

Patients in this arm would receive hybrid dose-fraction radiotherapy combined with immune checkpoint inhibitors.

Drug: Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors

Interventions

Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors DRUG

Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors

Also known as: no other interventions

Hybrid dose-fraction Radiotherapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• 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, large-cell carcinoma, adenosquamous carcinoma;
• Stage IVA and IVB confirmed by radiological examination (AJCC 8th Edition);
• Driven-genes negative including EGFR (Epidermal Growth Factor Receptor), ALK (Anaplastic Lymphoma Kinase), ROS1 (ROS Proto-Oncogene 1), KRAS G12C (Kirsten Rat Sarcoma Viral Oncogene), BRAF V600E (v-raf murine sarcoma viral oncogene homolog B1), MET exon14 (Mesenchymal Epithelial Transition Factor), RET (Rearranged during Transfection Proto-oncogene), NTRK1/2/3 (NeuroTrophin Receptor Kinase);
• First-line treatment of ICI±chemotherapy;
• Partial response (PR) or stable (SD) after first-line treatment;
• Signature of inform consent.

You may not qualify if:

• younger than 18 years old or older than 75 years old;
• ECOG\>1;
• Small-cell lung cancer and other neuroendocrine carcinoma;
• Non stage IV confirmed by radiological examination;
• Driven-genes positive including EGFR, ALK, ROS1, KRAS G12C, BRAF V600E, MET exon14, RET, NTRK1/2/3;
• First-line treatment of other therapy rather than ICI±chemotherapy;
• Complete response (CR) or progression (PD) after first-line treatment;
• Contraindications for radiotherapy, chemotherapy and ICI;
• 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

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 74 patients with metastatic driven-genes negative non-small cell lung cancer to receive the combination of hybrid dose-fraction radiotherapy with ICI

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)