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

NCT07149649 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SAKK 19/24
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 11

Brief Summary

This study investigates whether adding magnesium to the standard chemo-immunotherapy for advanced non-small cell lung cancer (NSCLC) can improve treatment outcomes. Magnesium is important for immune function, and low levels during chemotherapy are common. Participants are randomly assigned to receive either magnesium or a placebo, both as infusions and tablets. Neither the participants nor the doctors know who receives which treatment. The study compares the two groups to see if magnesium helps and how well it is tolerated.

Conditions

Metastatic NSCLC - Non-Small Cell Lung Cancer

Keywords

Magnesium supplementation; Magnesium aspartate hydrochloride; Placebo; Non-Small Cell Lung Cancer; phase II/phase III; unresectable stage III NSCLC; metastatic stage IV NSCLC; double-blind randomized

Outcome Measures

Primary Outcomes (2)

• Primary endpoint of Phase II part: Progression-free survival (PFS)

  PFS defined as time from randomization to progression according to RECIST 1.1 criteria or death. Patients not experiencing an event will be censored at the date of the last available assessment before initiation of a new anti-cancer treatment, if any.

  From randomization to PD or death, up to 10 years

• Primary endpoint of Phase III part: Overall survival (OS)

  OS defined as the time from randomization until death due to any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

  From randomization to PD or death, up to 10 years

Secondary Outcomes (3)

• Toxicity - Intermediate endpoint for the adaptive decision to expand, or not, into a Phase III

  All adverse events: from baseline until end of treatment, deaths: until end of follow-up, up to 10 years

• Number of participants discontinued any treatment component.

  from baseline until end of treatment, deaths: until end of follow-up, up to 10 years

• Event-free survival (EFS)

  From randomization to PD, 2nd tumor or death, up to 10 years

Study Arms (2)

Magnesium

EXPERIMENTAL

Platinum-based chemo-immunotherapy every 3 weeks \+ Magnesium * intravenous at day 1 of each therapy cycle * peroral thrice daily (day 1-21)

Drug: Magnesiocard; Drug: Magnesium Diasporal

Placebo

ACTIVE COMPARATOR

Platinum-based chemo-immunotherapy every 3 weeks \+ Placebo * intravenous at day 1 of each therapy cycle * peroral thrice daily (day 1-21)

Other: Microcrystalline cellulose; Other: Isotonic saline solution 0.9%

Interventions

Magnesiocard DRUG

2.5 mmol film-coated tablets in addition to standard first line therapy

Magnesium

Magnesium Diasporal DRUG

4 mmol IV formulation in addition to standard first line therapy

Magnesium

Microcrystalline cellulose OTHER

Placebo film-coated tablets corresponding to Magnesiocard in addition to standard first line therapy

Placebo

Isotonic saline solution 0.9% OTHER

Placebo for injection corresponding to Magnesium Diasporal in addition to standard first line therapy

Placebo

Eligibility Criteria

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

You may qualify if:

• Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures;
• Histologically or cytologically confirmed diagnosis of NSCLC (adeno-, squamous-, large cell carcinoma or NSCLC not otherwise specified);
• Patients planned for systemic first-line therapy with a combination of a carboplatin-based doublet chemotherapy and a PD-1 / PD-L1 targeting immune checkpoint inhibitor;
• Patients not eligible for immune checkpoint inhibitor monotherapy irrespective of PD-L1 expression;
• Locally advanced unresectable stage III or metastatic stage IV disease (defined as TNM, according to 8th edition) not eligible for curative surgery and/or definitive (curative intended) chemoradiotherapy;
• No sensitizing EGFR mutation, METex14 skipping mutation, BRAF V600E mutation, ALK/ROS1/RET, NTRK1/2 gene rearrangements, HER2 mutations, amplifications detected in primary tumor or metastases;
• Have not received prior systemic treatment for their metastatic NSCLC. Patients who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for nonmetastatic disease are eligible if the therapy was completed at least 12 months prior to the diagnosis of metastatic disease;
• Patients with treated and stable CNS metastases are eligible, provided they meet the following criteria:
• No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed
• No stereotactic radiation or whole-brain radiation within 14 days prior to registration.
• Patients with known HIV-infection, who are at low risk of AIDS-related outcomes, are eligible, provided they meet the following criteria:
• CD4+ T-cell counts are ≥ 350 cells/ųL
• No history of AIDS-defining opportunistic infection within past 12 months
• Patients have been on antiretroviral therapy (ART) for \> 4 weeks before registration and have a HIV viral load \< 400 copies/mL;
• Patients with a prior malignancy and treated with curative intention are eligible if the treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence;

You may not qualify if:

• Plasma magnesium concentration \< 0.4 mmol/l or \> 1.2 mmol/L
• Treatment with any anti-cancer therapy within 21 days prior to registration (excluding hormonal therapy or anti-cancer surgery). Any previous anti-cancer therapy must have been administered with curative intent;
• Treatment with radiotherapy within 14 days prior to registration (except for local pain control);
• Patients planned for cisplatin-based chemo-immunotherapy;
• Treatment with any other experimental drug within 28 days of registration;
• Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia);
• Atrioventricular (AV) block of any degree unless being treated with cardiac pacemakers;
• Bradycardia \<40/min at steady state;
• Active chronic Hepatitis C or Hepatitis B infection or any uncontrolled active systemic infection, needing antibiotic treatment within 14 days before registration;
• Known history of tuberculosis, known history of relevant primary immunodeficiency, known history of allogeneic organ transplant, receipt of live attenuated vaccine within 28 days prior to registration;
• Diagnosis of myasthenia gravis;
• Concomitant or prior use of immunosuppressive medication within 28 days before registration, with the exceptions of:
• intranasal and inhaled corticosteroids
• systemic corticosteroids ≤ 10 mg/day of prednisone, or a dose equivalent corticosteroid,
• premedication for chemotherapy;

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (11)

Tumorzentrum Aarau - Hirslanden TZA

Aarau, 5001, Switzerland

Location

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

St. Claraspital

Basel, 4058, Switzerland

Location

Universitätsspital Basel

Basel, 4058, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Kantonsspital Olten

Olten, 4600, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Spital STS AG

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Aspartic Acid; levulinic acid; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Excitatory Amino Acids

Study Officials

• Jonas Lötscher, MD, PhD

  CH - Universitätsspital Basel

  STUDY CHAIR

• Sacha Rothschild, Prof MD, PhD

  CH - Kantonsspital Baden

  STUDY DIRECTOR

• Christoph Hess, Prof MD, PhD

  CH - Universitätsspital Basel

  STUDY DIRECTOR

Central Study Contacts

Zuzanna Maniecka Moser, PhD

CONTACT

+41 31 389 91 91; trials@swisscancerinstitute.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinding procedures Patient randomization into the two treatment arms is double-blind. Neither the patient nor any of the investigators who are involved in the conduct of the trial, or the analysis of the trial data have knowledge of the assigned treatment arm. This level of blinding is maintained throughout the conduct of the trial unless there are compelling medical or safety reasons to alleviate the unblinding. On the sponsor's side, the Clinical Research Associates (CRA) performing source data verification, and the CDM-DM performing data management remain blinded for the entire duration of the trial. Blinding is performed by the authorized pre-wholesaler upon randomization of the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, randomized, double-blind, placebo-controlled, seamless phase II/III trial. In total, 230 patients will be included in the trial - 70 patients in phase II and 160 patients in phase III.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: September 2, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): March 31, 2035
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CH (11)