Clinical Effects of Alpha-Lipoic Acid in Advanced NSCLC

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Advanced Non Small Cell Lung Cancer (NSCLC)

In brief

Non-small cell lung cancer (NSCLC) is a common and aggressive type of lung cancer often diagnosed at advanced stages, with limited treatment options and poor prognosis. Oxidative stress, inflammation, and dysregulated signaling pathways contribute to tumor progression, metastasis, and chemotherapy resistance. Alpha-lipoic acid (ALA), a potent antioxidant with anti-inflammatory properties, has shown promise in preclinical and early clinical studies by reducing oxidative stress, enhancing chemotherapy efficacy, and improving immune response. The aim of this study is to evaluate the clinical effect and safety of oral ALA (600 mg daily) in combination with standard platinum-based chemotherapy in patients with advanced non-resectable Stage III or IV NSCLC. Primary outcomes include clinical benefit and tumor response, while secondary outcomes include 1-year progression-free survival, 1-year overall survival, chemotherapy toxicity, and quality of life.

Key facts

Study ID

NCT07574684

Run by

Ain Shams University

People needed

60

Starts

2026-04-20

Expected to finish

2027-04-20

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (>18 years old).
• Non-respectable Stage III and IV NSCLC.
• Patients ECOG PS of 0-2.
• With no-actionable or unknown driver mutation
• Planned to receive platinum doublets with or without immune checkpoint inhibitors.
• Adequate organ function defined as; Absolute neutrophil count of more than 1.5×109 cells per L, more than 100×109 platelets per L, conjugated bilirubin serum concentration of up to 1.5 times the upper limit of normal, serum concentrations of alkaline phosphatase and aminotransferases of up to 2.5 times the upper limit of normal, and creatinine clearance of more than 60 mL/ min.

You may not qualify if…

• History of hypersensitivity to alpha lipoic acid.
• Pregnancy or lactation.
• patients receiving medications that interact with alpha lipoic acid, such as:
• Iron supplements
• Thyroid medications
• Patients with severe cognitive impairments, neurological disorders (e.g., dementia, Alzheimer's disease), or severe psychiatric conditions that would interfere with the ability to comply with study protocols or follow-up
• Uncontrolled heart disease (e.g., recent myocardial infarction, congestive heart failure)
• Severe hypertension not controlled by medication
• Patients with brain metastases.

Full record on ClinicalTrials.gov

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