NCT07574684Not yet recruitingPhase 2
Clinical Effects of Alpha-Lipoic Acid in Advanced NSCLC
The Effect of Alpha Lipoic Acid on the Clinical Outcome of Advanced Non-Small Cell Lung Cancer Patients
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 Apr 2026
- Start date
- 20 Apr 2026
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Ain Shams University
- Diseases
- Lung cancer
- NCT number
- NCT07574684
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 20 Apr 2026 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients receiving medications that interact with alpha lipoic acid, such as:
- Thyroid medications
Other illness
- History of hypersensitivity to alpha lipoic acid.
- 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
Other
- Pregnancy or lactation.
- Iron supplements
- Patients with brain metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.