Clinical Effects of Alpha-Lipoic Acid in Advanced NSCLC

NCT07574684 | Not Yet Recruiting Phase 2

• 1 other identifier: REC # 449
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Advanced Non Small Cell Lung Cancer (NSCLC)

Keywords

Non small cell lung cancer; neuron specific enolase; alpha lipoic acid; survival; progression

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 2. Tumor Response Rate (ORR)

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

  1 year

Secondary Outcomes (5)

• 3.Progression-Free Survival (PFS)

  1- year of treatment

• 4. Overall Survival (OS)

  1 year

• 5. Serum Neuron-Specific Enolase (NSE) Levels

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

• 6. Chemotherapy Toxicity

  During treatment (up to 1 year)

• 7.Quality of Life (QoL)

  Baseline and during treatment up to 1 year

Study Arms (2)

intervention group

ACTIVE COMPARATOR

30 patients will receive oral Alpha Lipoic Acid 600 mg once daily in addition to platinum doublet for 6-8 cycles

Drug: Alpha Lipoic Acid 600mg

control group

NO INTERVENTION

30 patients will receive platinum doublet for 6-8 cycles

Interventions

Alpha Lipoic Acid 600mg DRUG

Alpha Lipoic Acid 600mg Tablet

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• 1. Clark SB, Alsubait S. Non-small cell lung cancer. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan. 2. El Agamawi AY, Tarrad MM, et al. Clinical and pathological characteristics of patients with non-small cell lung cancer: retrospective study. Al-Azhar Int Med J. 2025 Apr;6(4):Article 5. doi:10.58675/2682-339X.2891. 3. Molina JR, Yang P, et al. Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc. 2008 May;83(5):584-594. doi:10.4065/83.5.584. 4. Lababede O, Meziane MA. The eighth edition of TNM staging of lung cancer: reference chart and diagrams. Oncologist. 2018 Jul;23(7):844-848. doi:10.1634/theoncologist.2017-0659. 5. Jeon H, Wang S, et al. Update 2025: management of non-small cell lung cancer. Lung. 2025 Mar 25;203(1):53. doi:10.1007/s00408-025-00801-x. 6. Saleem N, Habib A, et al. Phytocompounds as promising weapons against lung cancer: a review. Phytopharm Commun. 2024;4:57-68. doi:10.55627/ppc.004.001.0546. 7. Yan S, Lu J, et al. The multifaceted role of alpha-lipoic acid in cancer prevention, occurrence, and treatment. Antioxidants. 2024 Aug;13(8):897. doi:10.3390/antiox13080897. 8. Ferrigno D, Buccheri G, et al. Neuron-specific enolase is an effective tumour marker in non-small cell lung cancer. Lung Cancer. 2003 Sep;41(3):311-320. doi:10.1016/s0169-5002(03)00232-0. 9. Pingali U, Kammila S, et al. Effect of alpha-lipoic acid on neuropathic symptoms in diabetic neuropathy patients. Cureus. 2024 Sep 27;16(9):e70299. doi:10.7759/cureus.70299. 10. Petrella F, Rizzo S, et al. Stage III non-small-cell lung cancer: an overview of treatment options. Curr Oncol. 2023 Mar;30(3):3160-3175. doi:10.3390/curroncol30030239. 11. Nguyen H, Pellegrini MV, et al. Alpha-lipoic acid. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 12. Fogacci F, Rizzo M, et al. Safety evaluation of alpha-lipoic acid supplementation: a systematic review and meta-analysis. Antioxid

  BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Disease Progression

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• May shawky, PHD

  Clinical Pharmacy department faculty of pharmacy Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

omnia Ahmed, Bachelor

CONTACT

02201096908315; omnia.ms2324003@pharma.asu.edu.eg

Rana sayed, PHD

CONTACT

00201208164247

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective, parallel-group, open label, randomized controlled study will be carried out on NSCLC patients at the Clinical Oncology and Nuclear Medicine department, Ain Shams University Hospitals, Cairo, Egypt. Sixty patients will be recruited in the study and will be stratified based on gender and immune checkpoint inhibitors receiving, followed by permuted block randomization to be assigned to either of the following groups: Alpha lipoic acid group: 30 patients will receive oral alpha lipoic acid 600 mg once daily in addition to platinum doublet for 6-8 cycles. Control group: 30 patients will receive platinum doublet for 6-8 cycles.

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: May 8, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share