Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss Cancer Institute
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Magnesiocard
- Magnesium Diasporal
- Microcrystalline cellulose
- Isotonic saline solution 0.9%
Treatment groups
230 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov