Clinical Effects of Alpha-Lipoic Acid in Advanced NSCLC

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

History of hypersensitivity to alpha lipoic acid.

Pregnancy or lactation.

Iron supplements

Thyroid medications

Trial design

Treatments tested in this trial

  • Alpha Lipoic Acid 600mg

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators