NCT06523673

Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer

Stereotactic Body Radiotherapy (SBRT) for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer (OPPRESS):A Randomized, Controlled, Open-label, Multi-Center Phase 3 Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are: Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy. Participants will: Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.

Detailed description

This study is a prospective, randomized, controlled, open-label, multi-center phase Ⅲ study of patients with stage IV NSCLC who developed oligo-progression after prior first-line chemotherapy with clinical benefit lasting for ≥3 months, aiming to evaluate the efficacy and safety of applying SBRT to treat oligo-progressive NSCLC. NSCLC patients with oligo-progression (≤5 extracranial progression sites) after ≥3 months of clinical benefit by first-line systemic therapy and who are suitable for SBRT will be screened to meet the enrollment criteria after signing the informed consent and will be randomized to the SBRT/standard of care (SOC) groups according to the stratification ratio of 1:1. SBRT group: SBRT was performed on the progressive sites. During SBRT treatment, maintenance therapy was with ICI or bevacizumab or combined single-agent chemotherapy. Evaluation was performed after completion of SBRT treatment. After the occurrence of progression that is no longer suitable for SBRT treatment, switch to second-line systemic therapy (same as SOC). SOC group: Second-line systemic therapy is based on docetaxel or albumin-paclitaxel. The combination of immunotherapy or anti-vascular drugs is evaluated by the study physician. The specific drug regimen is determined in conjunction with the patient's wishes. Palliative radiotherapy is acceptable.

Conditions

• Metastatic Non-Small Cell Lung Cancer
• NSCLC Stage IV
• OligoProgressive Metastatic Disease

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiotherapy	The dose of radiation therapy is determined by the radiologist based on the clinical parameters of the lesion, including tumor size and location. In most cases, radiotherapy fractionation regimens range from 27-30 Gy/3 Fractions or 30-50 Gy/5 Fractions, and appropriate radiotherapy doses covering 27-70 Gy/3-10 Fractions can also be selected by the radiologist based on radiation limitations of neighboring endangered organs.
DRUG	second-line systemic therapy	a second-line docetaxel/albumin-bound paclitaxel-based systemic therapy regimen

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-07-26
• Last updated: 2024-08-30

Locations

1 site across 1 country: China