Sodium glycididazole to reduce side effects of chemoradiotherapy in lung cancer

Sodium Glycididazole Reduces Chemoradiotherapy-related Adverse Reactions During Concurrent Chemoradiotherapy for Locally Advanced Non-small Cell Lung Cancer

This study is testing if sodium glycididazole can help reduce side effects from chemoradiotherapy in patients with advanced lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06667622 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and toxicity of sodium glycididazole when combined with concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer following neoadjuvant treatment. It aims to inhibit radiation esophagitis, reduce radiation pneumonitis, and lymphopenia while assessing the sensitization effect of sodium glycididazole on anti-tumor activity. Additionally, the study will explore the correlation between specific biomarkers and the toxicity of the treatment, ultimately constructing a predictive risk model for radiation-related side effects.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable stage II-III non-small cell lung cancer who have undergone neoadjuvant therapy and have adequate organ function.

Not a fit: Patients with a history of previous radiotherapy or those with mixed small cell and non-small cell lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the adverse reactions associated with chemoradiotherapy, improving patient quality of life and treatment outcomes.

How similar studies have performed: While there may be studies exploring similar interventions, this specific combination of sodium glycididazole with concurrent chemoradiotherapy appears to be novel.

Eligibility criteria

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed non-small cell lung cancer.
2. Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvant therapy.
3. ECOG PS 0-2
4. Adequate organ and bone marrow function.

Exclusion Criteria:

1. History of previous radiotherapy.
2. The previous immune-related pneumonitis ≥ grade 2.
3. Local lesions require surgery.
4. History of another primary malignancy.
5. History of active primary immunodeficiency.
6. Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
7. For any unmitigated toxicity during pre-study chemoradiotherapy.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lei Deng, MD

Conditions Chemoradiotherapy