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Clinical Effects of Alpha-Lipoic Acid in Advanced NSCLC

ConditionAdvanced Non Small Cell Lung Cancer (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Alpha Lipoic Acid 600mg

    Drug

    Alpha Lipoic Acid 600mg Tablet

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: intervention groupActive comparator 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

1. Clinical Benefit Rate (CBR)

Proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria.

Time frame
1 year
2

2. Tumor Response Rate (ORR)

Proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

Time frame
1 year

Secondary outcomes

1

3.Progression-Free Survival (PFS)

Time from start of treatment until disease progression or death from any cause, whichever occurs first (measured in months)

Time frame
1- year of treatment
2

4. Overall Survival (OS)

Time from start of treatment until death from any cause (measured in months).

Time frame
1 year
3

5. Serum Neuron-Specific Enolase (NSE) Levels

Change in serum NSE concentration (measured in ng/mL) from baseline to post-treatment.

Time frame
At Baseline and after 2-3 chemotherapy cycles (each cycle is 21 days)
4

6. Chemotherapy Toxicity

Incidence and severity of adverse events graded according to NCI-CTCAE v5.0.

Time frame
During treatment (up to 1 year)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: