What is magnesium studying for advanced non-small cell lung cancer?

This trial is evaluating whether adding magnesium supplements to standard chemo-immunotherapy can improve treatment outcomes for advanced NSCLC. Researchers want to see if correcting magnesium deficiency helps immune response against the cancer. The study is sponsored by the Swiss Cancer Institute and aims to assess both safety and effectiveness.

Who may be eligible for this advanced non-small cell lung cancer clinical trial?

Adults aged 18 or older diagnosed with NSCLC who are scheduled for first-line chemo-immunotherapy with carboplatin-based chemotherapy and immune checkpoint inhibitors may be eligible. Participants should have adequate organ function and no recent use of magnesium supplements. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced non-small cell lung cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID07149649

Study of Magnesium Added to Standard Chemo-immunotherapy for Advanced Unresectable or Metastatic Non-Small Cell Lung Cancer

Led by Swiss Cancer Institute · Updated on 2026-07-16

230

Participants Needed

Research Sites

221 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether adding magnesium to the standard chemo-immunotherapy can improve treatment outcomes in patients with advanced non-small cell lung cancer NSCLC that is unresectable stage III or metastatic stage IV. Magnesium plays a key role in immune function, and its levels often drop during chemotherapy, which may affect how well immune therapies work. This trial is a randomized, double-blind, placebo-controlled phase IIIII study assessing if magnesium supplementation enhances immune response and clinical results. Participants are randomly assigned to one of two groups one receiving standard platinum-based chemo-immunotherapy plus oral magnesium tablets three times a day and intravenous magnesium sulfate on chemotherapy days the other receiving the same chemo-immunotherapy plus matching placebo tablets and intravenous infusions. The study monitors magnesium levels centrally through blood and urine samples. The phase II part focuses on safety and progression-free survival, and if successful, the study expands seamlessly into phase III, which measures overall survival. During the trial, patients undergo regular assessments including monitoring of adverse events, immune-related biomarkers, magnesium levels, and quality of life. Data is collected through validated electronic forms with quality checks and source verification to ensure accuracy. Participants are followed for up to 10 years to evaluate progression-free survival, overall survival, event-free survival, and treatment tolerability. This study explores a cost-effective way to potentially improve immune control of NSCLC by addressing magnesium deficiency caused by chemotherapy.

CONDITIONS

Brief Title

Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Written informed consent according to Swiss law and ICH GCP E6 before any trial procedures
Confirmed diagnosis of NSCLC including adenocarcinoma, squamous, large cell, or not otherwise specified
Planned first-line treatment with carboplatin-based doublet chemotherapy and PD-1/PD-L1 immune checkpoint inhibitor
Not eligible for immune checkpoint inhibitor monotherapy regardless of PD-L1 status
Locally advanced unresectable stage III or metastatic stage IV disease not suitable for curative surgery or chemoradiotherapy
No sensitizing EGFR, METex14, BRAF V600E mutations or ALK/ROS1/RET/NTRK1/2 rearrangements or HER2 alterations
No prior systemic treatment for metastatic NSCLC; prior curative adjuvant or neoadjuvant therapy allowed if completed at least 12 months earlier
Stable, treated CNS metastases without ongoing corticosteroids and no recent brain radiation within 14 days
HIV infection allowed if low risk with stable CD4+ counts, no recent AIDS infections, on ART with low viral load
Prior malignancy allowed if treated curatively with no evidence of disease for at least 2 years or low recurrence risk
Measurable disease per RECIST v1.1
Age 18 years or older
ECOG performance status 0-1
Adequate bone marrow, liver, and kidney function per local guidelines
Women of childbearing potential must use effective contraception, not be pregnant or lactating, and have a negative pregnancy test before inclusion
Men must agree not to father a child during treatment and for 6 months after last dose

You will not qualify if you...

Plasma magnesium concentration below 0.4 mmol/L or above 1.2 mmol/L
Anti-cancer therapy within 21 days before registration except hormonal therapy or surgery with curative intent
Radiotherapy within 14 days before registration except local pain control
Planned cisplatin-based chemo-immunotherapy
Use of any other experimental drugs within 28 days before registration
Severe or uncontrolled cardiovascular disease including recent myocardial infarction or serious arrhythmias
Atrioventricular block unless treated with pacemaker
Bradycardia less than 40/min at steady state
Active chronic Hepatitis B or C or uncontrolled active systemic infection requiring antibiotics within 14 days
History of tuberculosis, relevant primary immunodeficiency, organ transplant, or recent live vaccine
Diagnosis of myasthenia gravis
Use of immunosuppressive medication within 28 days except low-dose corticosteroids and premedication for chemotherapy
Prior oral or intravenous magnesium treatment within 14 days before registration
Unwillingness to stop oral magnesium including over-the-counter or lifestyle products
Use of drugs contraindicated with the trial medication
Known hypersensitivity to any trial drugs
Any serious medical, psychiatric, psychological, familial, or geographic condition that may interfere with treatment or compliance

Research Team

Gisela Müller, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Study of Magnesium Added to Standard Chemo-immunotherapy for Advanced Unresectable or Metastatic Non-Small Cell Lung Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria